QA Specialist

1 day ago

Tuas, Singapore Pfizer Full time

:
We are looking for individual who can work independently, have good interpersonal skill and good laboratory compliance. The incumbent will have the responsibility for QA operational oversight for the site Quality Control (QC) and ensures overall quality integrity of the chemical and microbiological laboratories to support the testing, approval and release of API. The incumbent is also Quality approval for analytical and cleaning method validation/verification, lab equipment qualification, laboratory procedures, and analytical reports etc and ensure adherence to site procedures and Pfizer Quality Standard /regulatory requirements. The incumbent will also be the Quality approval for laboratory investigations/deviations and change controls related to laboratory.

The incumbent will establish, maintain, coordinate and support the Quality Systems Compliance such as Change Control, Deviation, Internal Audits, Regulatory Inspections and GMP Training to support the various business processes on site in full compliance with GMP predicate rules and Pfizer’s internal requirements.
- Review and approve change control, deviation, customer complaint reports to ensure consistency with quality standards and quality of deliverables as and when required.
- Drive quality culture and promote GMP compliance behaviors to the site.
- Ensure site compliance to Pfizer Quality Standards (PQS) and ICH guidelines.
- Provide oversight to the site GMP operations to ensure products produced in compliance with the Pfizer Quality Standards (PQS).
- Collaborate with cross functional teams to improve quality systems.
- Understand regulatory expectations and support site inspection readiness.

POSITION RESPONSIBILITIES:

- Review and approve GMP documentation and ensure their compliance to Pfizer Quality Standards (PQS).
- Ensure adherence to quality procedures, regulatory requirements and cGMPs.
- Improve quality assurance systems, as necessary.
- Maintain current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.
- Conduct GMP walkthrough to ensure the internal controls are effective. Conduct external audits to ensure adequate oversight to suppliers and collaborate with supplier to reduce starting material quality issues.
- Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
- Support the maintenance of validated stated of GMP systems and processes.

EDUCATION:
A Bachelor Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience.

EXPERIENCE:
For Senior QA Specialist: A minimum of 5 years’ experience in Quality Assurance rolewithin the pharmaceutical industry

For QA Specialist: A minimum of 1 year experience in pharmaceutical industry or related industry is preferred. Fresh graduate will still be considered.

For Diploma holders, a minimum of 3 years experiences in pharmaceutical industry or related industry.

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control

LI-PFE

  • QA Specialist Operation

    1 week ago

    Tuas, Singapore Randstad – Lonza Full time $60,000 - $120,000 per year

    Job Description:As a Specialist, QA (CGT) at Lonza, you will support day-to-day Quality Assurance activities in accordance with approved SOPs and policies for a multi-product, cGxP contract manufacturing facility. You will play a key role in providing QA oversight for operations, compliance, and documentation, ensuring that products meet the highest quality...

  • Specialist 3, QA

    7 days ago

    Tuas, Singapore Lonza Full time

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Specialist 2, QA

    5 days ago

    Tuas, Singapore Lonza Full time

    Singapore, Tuas SingaporeToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their...

  • Specialist - QA Ops - Manufacturing Mgmt

    2 weeks ago

    Tuas, Singapore Novartis Full time

    **Summary**: Job Description Summary This role support/provide quality oversight in ensuring a smooth manufacturing operation, new product launches/transfer in a compliant/timely manner, drug substance batch review/release are in full gmp compliance to regulatory standards and ensures quality strategy/continuous improvement are driven in alignment to site...

  • Specialist 3, QA

    2 weeks ago

    Tuas, Singapore Lonza Full time

    Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely...

  • Specialist, QA

    3 days ago

    Tuas, Singapore Lonza Full time

    **Singapore, Tuas Singapore** Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers....

  • Senior Specialist 1, QA

    7 days ago

    Tuas, Singapore Lonza Full time

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Specialist 1, QA

    3 days ago

    Tuas, Singapore Lonza Full time

    Singapore, Tuas SingaporeToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their...

  • Specialist 3, QA

    1 week ago

    Tuas, Singapore Lonza Biologics Porriño SLU Full time $60,000 - $120,000 per year

    Overview Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Specialist 1, QA

    1 day ago

    Tuas, Singapore Lonza Full time

    Singapore, Tuas Singapore Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their...