Total 1,414 Full-time qa specialist job vacancies in D22 Jurong, Jurong Island, Tuas

As a part of our team of more than 5000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Senior Manager QA (QA Compliance)
The role is responsible for internal audits, external audits and regulatory inspection management and supporting Quality processes. Acts as a check and balance for internal operations, ensures alignment to global quality, internal and general GxP requirements for vendor and material management. Your main responsibilities are:

• Responsible to lead and direct the assigned Quality Process
• Provides QA oversight of the assigned Quality Process to ensure that products are processed, manufactured, stored and distributed according to applicable current GxP and regulations
• Provides QA oversight of the assigned Quality Process to ensure that facilities, equipment, materials, processes and procedures comply with applicable current GxP and regulations
• Implements, maintains and reviews the assigned Quality Process according to applicable current GxP and regulations
• Owns policies and procedures of the assigned Quality Process where applicable.
• Partners with global and communicates to functions to ensure the assigned Quality Process is executed according to established policies and procedures
• Reviews/approves and provides inputs for procedures, documents, records, deviations, investigations, corrective action/preventive actions, change controls and gap assessments associated with the assigned Quality Process
• Ensures deviations from assigned Quality Process are documented and investigated
• Ensures QA personnel are qualified and trained to perform assigned tasks
• Support technology transfer activities.
• Develops strategies for assigned Quality Process to be fit for purpose, site operation readiness, including continuous improvements and ensure a state of inspection readiness
• Leads inspection and audit preparations
• Lead/ coordinates the relevant forums/activities of the assigned Quality process (e.g. Quality Management Review, Quality Risk Review, APQR)
• Escalates quality and compliance risks to Head of Department, QA
• Supports improvement initiatives, programs and projects of the assigned Quality Process
• Build, maintain and develop a team to support the deliverables of this assigned Quality Process

What you have to offer.

• University degree/Advanced Degree in Science (medicine, pharmacy, chemistry, biotechnology, biology or equivalent).
• At least 12 years’ professional working experience in Quality Management System in the pharmaceutical/biotechnology/medical device industry with more than 3 years people management experience.
• Extensive knowledge in Quality Management System concepts and strong understanding of pharmaceutical business and regulatory governance/framework
• Experiences with collaborations with global multidisciplinary functions involved in drug development and manufacturing
• Ability to be agile and effectively collaborate in a dynamic, cross-functional environment
• High degree of conscientiousness and diligence
• Constructive work habits, flexibility, solution orientation, job ownership, quality awareness, and very good planning and organizational skills in a fast-paced environment
• Self-starter and learning capacity
• Sense of ownership and honesty (proactive handling of errors)
• Ability to navigate through ambiguity and rapid growth and adapt to change, especially in a start-up environment
• Expectation to be hands on, interactive and display practical leadership
• Good communication skills
• Fluent in written and verbal English

Benefits for you:

We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.

How to apply:

Apply now and simply send us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details by using our online form.

Please note:

• Only applications sent via our online form shall be considered.
• Only Candidates with the right qualifications and relevant experience shall be shortlisted and
• Incomplete applications shall be rejected.
• BioNTech will run a background check during the hiring process

We are looking forward receiving your application.

• BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

Responsibilities:-

1. Inspect outgoing parts and incoming sub-contracted parts according to established procedure / specification of inspection and carry out Incoming Process Inspection.

2. Maintain quality record and file quality data.

3. Highlight quality problems discovered to the QA Manager and Factory Manager / Production Manager / Asst. Production Manager for action.

4. Ensure that all non-conforming products are not mixed with good products prior to disposition.

5. Authorise the rejection of parts if found unsatisfactory.

6. Authorise the release of conforming parts to be sent to the store for subsequent delivery to customers.

7. Perform factory routine test and check of switchboards completed in the workshop.

8. Testing and commissioning of switchboards on board vessels or on-site to the satisfaction of customers; and attend to warranty claims / quality complaints.

9. Conduct official tests on the switchboards which require witnessing by surveyors or consultants and also maybe with the presence of customers.

10. Assist the Manager in quality responsibilities and achieving quality objectives.

11. Maintain good housekeeping in the QA Department.

12. Observe and adhere to safety rules during the performance of every task.

13. Ensure the use of calibrated instrument for inspection.

14. Initiate action to prevent the occurrence of Product Non-Conformity.

15. Initiate, recommend or provide solutions to problem detected.

16. Verify the implementation of solutions.

17. Control further processing and delivery of Non-Conforming products until the deficiency has been corrected.

18. Carry out other responsibilities as and when assigned by the superiors.

19. Follow the procedures of Quality Management System for effective implementation and control.

P/S - Candidate who requires a work pass to work in Singapore need not apply.

Job Description

• To ensure ongoing compliance with the PIC/S Guideline for GMP.
• To achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvement; implementing change.
• Develops and implements a practical system for Quality Management System activities to facilitate smooth, timely workflows in the performance of job function.
• To provide guidance, interpretation, information on regulations, laws and industry guidance that affect pharmaceutical industry.
• Serve as a SME in matters relating to quality assurance and cGMP.
• Ensure facility follows applicable quality management directives such as SOPs, manuals, policies, procedures, work instruction, etc.
• Responsible for reviewing, trending and investigating excursions of environmental monitoring and supportive utilities data.
• The inspection and investigation of product recalls and product complaints to look into factors which has affect product quality.
• Acts as the Authorized Person to perform batch release and ensure each batch of medicinal products are manufactured and checked in compliance with the laws in force in the country and in accordance with the requirements of the Marketing Authorization.
• Reviews, approves or authorizes written procedures and other documents, including amendments.
• Oversees various quality management systems and analyze trending.
• Reviews and approves deviations and CAPA.
• Review, approves and implement changes according to established Change Control procedure.
• Coordinates and participates in quality risk management activities.
• Initiates investigation for product complaints, reviews and approves corrective/preventive actions associated.
• Coordinates product recalls, associated reconciliation, documentation and investigations.
• Reviews, approves and monitors suppliers of materials.
• Reviews, approves and monitors contract manufacturers and providers of other GMP related outsourced activities.
• Ensures validation and qualification are carried out according to schedule.
• Provides training or ensures appropriate training is provided to QA staffs.
• Monitors compliance of the organization with the requirements of Good Manufacturing Practice via Internal Audit.
• Coordinates management reviews of process performance, product quality and Pharmaceutical Quality
• System and advocates continual improvement
• Ensures timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management.

Requirements

• ISO/GMP in Pharmaceutical Experience will be prioritize
• At least bachelor degree, post graduate diploma in any science, or others filed related to pharmaceutical
• Minimum 7-8 years experience
• Well versed in computer skill especially in excel and other Microsoft office skills and knowledge in Navision is preferred.
• Close attention to details is essential
• Must be able to perform each essential duty satisfactory and in timely manner
• Independent & communication skills

Job Description

• Assist in training for staff for quality section-related activities when required.
• Maintain laboratory workplace and equipment.
• Perform all quality procedures and maintain proper documentation.
• Perform the required quality inspection by strictly following Work Instructions, Procedures and notify QA Engineer of problems.
• Generate any required reports of inspections.
• First Article Inspection for new parts.
• Support quality verification work related to quality issue.
• Create CMM or smart scope program as and when needed.
• Any other task assigned by QA Engineer

Requirements

• Minimum NITEC/Diploma Level or equivalent
• Preferably with 1-2 years related working experience in similar job scope
• Preferably in Manufacturing industries, Production department.
• Preferably with experience of using CMM or smart scope machine.
• Able to interpret mechanical drawing and basic knowledge of Geometric Dimensioning and Tolerancing (GD&T).
• Able to use basic measuring instruments like calliper, micrometer and profile projector.
• Proficient in computer and Microsoft Office Tools.
• Good math and technical skills.
• Understanding of quality control standards and testing techniques
• Good work attitude & interpersonal communication skill, self-motivated, independent, team player and willing to learn.

Job Description

Responsibilities

· Must possess hand-on experience to correlate, investigate and

resolve matters pertaining to quality information

· Co-ordinate with various departments and customer on quality

issues

· Follow-up other duties as required.

· Strong analytical, meticulous and problem solving skills

· Highly motivate and pro-active personality, with good

communication and interpersonal skills

· Knowledge and experience in ISO 9001, IATF 16949 and ISO 13485

Quality System would be advantage

· Pragmatic,hands-on and capable for multi-tasking

Requirements

· Diploma in Manufacturing/Mechanical Engineering/Quality or equivalent

· Minimum 3-4 years relevant experience

· Able to start work within short notice/immediately will be advantageous

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Senior Manager QA (QA Operations & Release)
This role is responsible and ensures that operations are in alignment and compliant with global Quality, internal and general GxP requirements. Ensures that raw materials are tested meeting specifications and DS, DP are produced meeting the specifications per the dossier and approved appropriately for release.

He/she has a strong commitment to drive a quality mindset culture, safety, health and environment (SHE) compliance for the site.

Your main responsibilities are :

• Lead and direct the assigned Quality Process
• Provides QA oversight of the assigned Quality Process to ensure that products are processed, manufactured, stored and distributed according to applicable current GxP and regulations
• Provides QA oversight of the assigned Quality Process to ensure that facilities, equipment, materials, processes and procedures comply with applicable current GxP and regulations
• Implements, maintains and reviews the assigned Quality Process according to applicable current GxP and regulations
• Owns policies and procedures of the assigned Quality Process where applicable.
• Partners with global and communicates to functions to ensure the assigned Quality Process is executed according to established policies and procedures
• Reviews/approves and provides inputs for procedures, documents, records, deviations, investigations, corrective action/preventive actions, change controls and gap assessments associated with the assigned Quality Process
• Ensures deviations from assigned Quality Process are documented and investigated
• Ensures QA personnel are qualified and trained to perform assigned tasks
• Support technology transfer activities.
• Develops strategies for assigned Quality Process to be fit for purpose, including continuous improvements and ensure a state of inspection readiness
• Supports inspection and audit preparations
• Participates in inspections, audits and Quality Management Review
• Escalates quality and compliance risks to Head of Department, QA
• Supports improvement initiatives, programs and projects of the assigned Quality Process
• Build, maintain and develop a team to support the deliverables of this assigned Quality Process
• Other responsibilities may be assigned by the manager

What you have to offer :

• At least 12 years’ professional working experience in Quality Management System in the pharmaceutical/biotechnology/medical device industry.
• Extensive knowledge in Quality Management System concepts and strong understanding of pharmaceutical business and regulatory governance/framework
• Experiences with collaborations with global multidisciplinary functions involved in drug development and manufacturing
• Ability to be agile and effectively collaborate in a dynamic, cross-functional environment
• High degree of conscientiousness and diligence
• Constructive work habits, flexibility, solution orientation, job ownership, quality awareness, and very good planning and organizational skills in a fast-paced environment
• Self-starter and learning capacity
• Sense of ownership and honesty (proactive handling of errors)
• Ability to navigate through ambiguity and rapid growth and adapt to change, especially in a start-up environment
• Expectation to be hands on, interactive and display practical leadership
• Good communication skills
• Fluent in written and verbal English

Benefits for you:

We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.

How to apply:

Apply now and simply send us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details by using our online form.

Please note:

• Only applications sent via our online form shall be considered.
• Only Candidates with the right qualifications and relevant experience shall be shortlisted and
• Incomplete applications shall be rejected.
• BioNTech will run a background check during the hiring process

We are looking forward receiving your application.

• BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

1. Preparation, execution and review of computer system validation protocols and reports.

2. Preparation and management of CSV deliverables for laboratory instruments and systems, manufacturing equipment, utility systems, IT, and enterprise systems.

3. Ensure the Computer System Validation is in alignment with the Validation Master Plan for Computer Systems.

4. Ensure timely completion of all validation related activities including computer system, equipment, utilities, and facility with compliance.

5. Perform assessment of vendor documents for CSV deliverables.

6. Conduct risk assessments to identify potential risks associated with computerized systems, including data integrity, security, and regulatory compliance.

7. Preparation and review of standard operating procedures to establish and maintain the quality system of the organization.

8. Participate in CFT meeting related to IT systems and ensure the completion of pending actions.

9. Periodic Review of IT application and systems implemented and compilation of reports.

Education and Experience

Diploma or Degree in IT or equivalent.

A minimum of 5-7 years’ relevant experience in pharmaceutical manufacturing environment.

Experience in electronic validation system, QMS, ERP system, SCADA, is preferred.

Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer.

• Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines.
• Execution of qualification and validation activities including process, cleaning, computer system, equipment, utilities, and facility.
• Candidate must have knowledge and experience of qualification/validation principles and their practical application.
• Preparation and review of process and cleaning validation protocols and reports.
• Coordinate with the cross functional team and external service provider to meet qualification & validation schedules and maintain equipment, systems, and processes in validated state.
• Review equipment and process related change control; perform Risk Assessment to determine criticality of the proposed changes.
• Write, review, and revise validation SOPs in compliance with regulatory guidelines.
• QA oversight and/or review during the validation process.
• Manage incidents and deviations related to validation & qualification.
• Perform compliance reviews of all applicable deviations, investigations, and CAPAs related to qualification and validation.
• Review and suggest continuous improvements to the Validation Master Plan, current quality system practices, validation protocols and procedures for newly installed equipment, and overall validation strategies.
• Cross train and develop expertise in other areas of validation.
• Must be able to interact and lead effectively in a team-based environment.
• Familiarity with regulatory/compliance environment.

EDUCATION & EXPERIENCE

• Degree a scientific discipline or equivalent.
• Experience in a regulated industry preferred.
• A minimum of 5-7 years’ relevant experience in pharmaceutical manufacturing environment.
• Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer.
• We regret only shortlisted candidates will be contacted.

Job Duties

• Support QA Team to implement ISO22000 for our new warehouse.
• Undertake the full spectrum of quality assurance function. Raw material checks, processing check, quality control and critical control points check, final product verification, supplier evaluation.
• Ensure hygiene and cleanliness of premises and food processing facilities are of high standards.
• Conduct a training of staff in terms of food hygiene and safety.
• Any other appropriate duties and responsibilities as assigned.

Job Specifications

• A Diploma in Food science & technology or related discipline.
• Strong communication, writing and inter-personal skills.

Key Performance Expectations

• To ensure timely response to any quality or safety issues or problems arising.
• To enforce food safety requirements and meet the necessary authority and standards requirements.
• Compliance with all audit requirements by relevant regulatory and certification bodies.
• Accurate food safety and quality records and documents keeping.
• Great team player with the ability to work with minimal supervision.

Period of Contract: 6 months contract job (2nd September 2024 to 3rd March 2025)

Working days : 5 days per week

Location of Work

No. 24 Tuas Avenue 12, Singapore 639041 and 1550 Bedok North Avenue 4, #05-15 & #01-17 Bedok Food City, Singapore 489950

Main Duties and Responsibilities:

• Manage and coordinate all Quality activities on site.
• Maintain compliance and administration of the company’s H&S, ISO, GMS systems, and all Regulatory processes, policies, and procedures in line with relevant legislation and company requirements.
• Assist in all site Vendor, Internal, Customer and Surveillance audits.
• Management of customer complaints, ensuring effective and efficient closure, and the implementation of any corrective actions.
• Work with other internal departments to ensure the correct quality standards are agreed and met, in relation to the introduction of new products into production.
• Maintain calibration records for all calibrated equipment on site.
• Maintain and assist in updates to site ISO 9001:2015 Quality Management System.
• Review and update site QMS.
• Assist in incoming, in-process and final inspection process.
• Point of contact for customer concerns ensuring customer expectations are met and exceeded.
• Work with vendors on supplier quality complaints.
• Log and update corrective and preventive actions on site CAPA (Agile) system.
• Responsibility for new vendor set up, and maintaining site Vendor rating process.
• Complete customer quality documentation (COA/COC etc.)
• Work with Production and Engineering Department to complete Installation, Operational and Process Qualifications (IOPQ) on new equipment and material produced on site.
• Ensure training records are kept up to date.

Requirements:

• Diploma/Degree in any Engineering discipline.
• Minimum of 3 years of relevant working experience.
• Able to work independently and as a team with good prioritization skills.
• Good time management and communication skills.
• Possesses knowledge in QMS and ISO9001:2015 process.

Job Highlights

• Lunch provided
• Shuttle Bus(Pick up and drop off at various locations)

Job Description

• Generate/Approve COA
• Perform lab blends
• Check and approve Job Slips
• Advise on treatment/processing of old/ageing stocks, returned stocks and flushing oil, and develop consistent and systematic approach on the process (e. g. reblending)
• Test methods validation, management and training
• Investigate all quality defects and recommend corrective actions
• Support sales department on technical queries and explanation
• Support sales department in responding to quality issues and troubleshooting such issues faced by the customers
• Support toll-blending on new formulation updates from customers
• Support test oil requirements in formulation and conducting tests, investigation and provide explanations if test results are not within specs
• Support early stage technical discussions with potential customers
• Maintain and update PDS, MSDS database
• Maintain and update QMS/Quality manual with respect to ISO requirements
• Monitor and place order for lab consumables
• Maintain all lab equipment as necessary (calibration, preventive maintenance etc)
• Plan standby schedule for Chemical Engineers / Lab Techs to support operations during off-office hours (OT, PH)
• Conduct performance appraisal for Chemical Engineers/Lab Techs

Requirements:

• Candidate must possess at least Bachelor degree or above in science / engineering.
• Prefer to have minimum 3 years of related work experience in supervisory role.
• Proficient in MS Office applications, LIMS (prefer), Statical Tools (prefer)
• Candidates with prior work experience in lubricant/grease laboratory will be an added advantage.
• ISO17025 internal auditor/experience will be an advantage.
• Good planning, organizing, communication and interpersonal skills.

Responsibilities:

• Read and interpret geometrical drawings
• Perform First Article Inspection plan for all new molds, steel & electrode inspection and final mold inspection
• Generate and maintain quality reports and engineering documents
• Provide support to Senior Technician – QA to disseminate information to both internal departments and external customers on the measurements, results and defective parts (if any) of the products
• Prepare inspection work instructions
• Assist in document control
• Inform Production and Superior of any problem found with the products

Requirements:

• NITEC in Manufacturing Engineering, Precision Engineering or relevant.
• Knowledge and 1 to 2 years’ experience in calibration, GD&T and CMM
• Comfortable to work rotatiing shift (4pm - 1.20am / 10pm - 7.20am)

Interested applicants please email your resume via clicking Apply Now button below stating your current salary, expected salary, reason for leaving present/last job and date available

.

Only short-listed candidates will be notified.

Responsibilities

• Perform tooling inspection and evaluate First Articles to ensure components and products conform to specifications
• Generate detail inspection and reports as necessary; provide necessary supportive documentations for product qualifications / customer approvals
• Ensure completion of inspection activities according to planned schedule assigned by Supervisor or Manager
• Ensure compliance of equipment and tools use during inspection in accordance with calibration and preventive maintenance requirements
• Ensure First Articles are marked with product identification, status and traceability
• Support other departments, suppliers and customers on quality related issues
• Audit manufacturing process to ensure that quality management system is in place
• Generate monthly QPR report
• Train or educate junior inspector on measurement techniques
• Meet quality objectives set by management & comply to all QMS requirements
• Stand in for the QA Supervisor in her absence
• Other duties as and when assigned by Supervisor or Management
• Take reasonable care of workplace health and safety; abide by all EHS policies and procedures; cooperate with Management and colleagues in EHS initiatives

Requirements:

• Diploma in Precision Engineering or relevant
• Relevant experience in plastic injection mold making industry
• Knowledge and experience in SQC tools, ISO 9001, ISO 13485 QMS and GD&T

Note

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

Interested candidates are invited to apply online with a comprehensive resume, via the APPLY NOW button below.

We regret that only shortlisted candidates will be notified.

Responsibilities:

• Responsible for monitoring and ensuring the quality of all the operation aspects of the facility according to the established SOP, GMP, GDP and GLP practices and regulatory requirements
• Responsible to brief the new operators on the GMP and hygiene briefing
• Responsible to brief the relevant maintenance, quality control personnel on the GMP and hygiene briefing that require to entering the dispensing area and production area
• Investigation of Product Complaints
• Review of BMR
• Initiation & follow up of Change Control and Deviations
• Perform qualifications, the process and cleaning validation
• Any ad-hoc duties as assigned by the superior

Requirements:

• Bachelor’s Degree
• 3+ years’ experience
• Demonstrate experience and skills in conduct audit, supplier management and site inspection readiness
• Strong knowledge and understanding of Quality System functions, manufacturing / packaging processes, validation, engineering drawings and basic statistical processes
• Good technical writing skills and communication as well as presentation skills
• Working knowledge of Microsoft Office, Microsoft Project, Statistical Software

Mandatory Skills

· Proven experience as a Software Test Engineer or similar role.

· Proficient in JSON, API, and SQL.

· Experience in regression and end-to-end testing.

· Strong problem solving skill and attention to detail.

· Excellent communication skill.

· Ability to learn quickly and work in a fast-paced environment.

· Experience in writing clear, concise, and comprehensive test plans and test cases.

· Willingness to support BAU operations as needed.

Skillsets (Good to have)

· Familiarity with financial instruments and entities.

· Experience with performance testing.

· Knowledge of Agile/Scrum development principles.

· Experience with automated testing tools.

· Understanding of coding and scripting for automation purposes.

· Knowledge of continuous integration and continuous delivery (CI/CD) processes.

· Familiarity with version control systems like Git.

· Knowledge of software QA methodologies, tools, and processes

Brief Job Description

Responsibilities:

· The successful candidate for this role is expected to have a strong background in regression and end-to-end testing, with a deep understanding of JSON, API, and SQL. Familiarity with financial instruments and entities will be considered a plus.

· This role requires an individual who is a fast learner, able to quickly comprehend business requirements and translate them into effective test cases using our in-house automated regression tools.