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QA Specialist

3 weeks ago

Tuas, Singapore Pfizer Full time

Pfizer Singapore is recruiting permanent employees for manufacturing site expansion of Pfizer Asia Manufacturing Pte Ltd (PAMPL) in Singapore

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

Position Summary

The incumbent is a member of the Quality Assurance team. Under the supervision of the Senior Compliance / QA Manager, the incumbent will be responsible for the following:

- Management of site Standard Operating Procedures (SOPs) and documentation systems (including controlled copies management, document archival and retrieval) in accordance to Pfizer Quality Standards (PQS) and ALCOA principles.
- Drive quality culture and promote GMP compliant behaviours at the site.
- Support improvement of quality systems in collaboration with cross functional teams.
- Contribute to achieve our vision of being best in class manufacturing site, producing highest quality products in the safest way.
- Deploy and use Imex "way of working" for day to day operations, problem solving, escalation and continuous improvements.

How You Will Achieve It

**Responsibilities**:

- Author SOPs and associated GMP documentation related to site SOP management and documentation systems in accordance to PQS and ALCOA principles.
- Provide QA oversight of archival activities of hard copy GMP records into site archives and/or off-site facilities throughout required retention period to eventual records disposal, ensuring compliance with site SOPs.
- Manage control and issuance of GMP controlled documentation.
- Review and approve site documents (e.g. SOPs, forms) as document controller, ensuring adherence to site SOPs.
- Handle duties related to DPOC (Designated Point of Contact) and super user for PDOCs system (e.g. configuration changes, user administration and periodic reviews).
- Lead or support investigations related to documentation systems, as required.
- Implement improvements to site SOP management and documentation systems, as necessary.
- Maintain inspection readiness and provide documentation support for internal and external GMP inspections.
- Actively participate in GMP walk downs to ensure documentation systems are maintained in inspection ready state and adhere to site procedures.
- Participate in gap analysis of site procedures against PQS and propose required actions to address identified gaps and mitigate risks.
- Maintain current quality tracking systems and quality metrics to proactively identify trends and atypical observations.
- Uphold Pfizer's code of conduct and values.
- Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations.
- Collaborate with cross-functional teams to drive flawless execution.
- Actively participate in Safety initiatives, and perform investigation related to EHS (as needed).

Job Related Requirements:

- Demonstrate ability to act independently to resolve issues.
- Good verbal, written communication and presentation skills.
- Demonstrated ability to perform in a team.
- Possess a can-do / pride to succeed attitude
- Embrace the use of digital technology to scale and speed up every form of interaction and action.

**Qualifications**:

- Diploma / Bachelor Degree in Science/Chemical Engineering or equivalent
- For Degree holders: A minimum of 1 year experience in pharmaceutical industry or related industry.
- For Diploma holders: A minimum 3 years experience in pharmaceutical industry or related industry.
- Prior experience in GMP document control roles preferred.

Fully complete Covid-19 vaccination and could provide official medical certificate

Pfizer Singapore recruit permanent employees for manufacturing site expansion of PFIZER ASIA MANUFACTURING PTE LTD (PAMPL) in Singapore

Work Location Assignment: On Premise

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