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.
What You Will Achieve
The incumbent is a member of the Quality Assurance team. Under the supervision of the Senior QA Manager / Lead QA Specialist, the incumbent will be responsible for the following:
- Provide Quality Assurance oversight to site operations (primarily Production, Quality Control, Warehouse, Engineering) to ensure products produced are in compliance with Pfizer Quality Standards (PQS) and ICH guidelines.
- Work with supply chain and downstream / drug product sites to ensure timely delivery of quality products.
- Support regulatory team to file products and address regulatory queries in an accurate and timely manner.
- Understand regulatory expectations and support site inspection readiness.
- Drive quality culture and promote GMP compliant behaviours at the site.
- Drive 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:
- Review and approve GMP documentation (e.g. GMP forms, protocols, reports, cleaning records, batch records, work instructions) to ensure their compliance with PQS.
- Disposition intermediates and active pharmaceutical ingredients (API).
- Support control and issuance of GMP controlled documentation.
- Coordinate with cross-functional team to prepare Annual Product Record Reviews, discuss trends and atypical observations and recommend improvement actions.
- Participate in process risk assessments (e.g. FMEA) as part of new product introductions and/or process changes.
- Support logistics for internal and external GMP inspections.
- 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 and adhere to site procedures and PQS.
- 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.
- Handle investigations according to site procedures (as required).
- Support the maintenance of validated state of GMP systems and processes.
- 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, with appropriate escalations (as required).
- Strong 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
- Degree in Chemistry, Microbiology, Engineering or other Science related discipline.
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.
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