QA Specialist

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- Drive quality culture and promote GMP compliance behaviours 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.
- Oversee adequate quality oversight to supplier management to ensure starting materials used meet Pfizer Quality Standards (PQS).
- Work with supply chain and drug product sites to ensure timely delivery of quality products.
- Work with regulatory team to file products and address regulatory queries in an accurate and timely manner.

**POSITION RESPONSIBILITIES**:

- Responsible to review and approve master batch records and subsequent batch records associated with the manufacturing, packaging and labeling of intermediates and active pharmaceutical ingredients (API) to ensure batches produced are in compliance with Pfizer quality standards and regulatory registered specifications.
- Disposition the intermediates and active pharmaceutical ingredients (API).
- Review and approve cleaning records and procedures and ensure compliance with the Pfizer Quality Standards (PQS) and guidelines.
- 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.
- Handle product complaints. Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
- Maintain current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.
- Coordinate with cross-functional team to prepare Annual Product Record Reviews, discuss trends and atypical observations and recommend improvement actions.
- Conduct internal audits 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.
- Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner
- Qualify and manage suppliers according to Pfizer Quality Standards (PQS) and maintain accurate records of supplier status. Review and analyze the quality related issues from suppliers and recommend improvement action to mitigate compliance risk to Pfizer.

**ORGANIZATIONAL RELATIONSHIPS**
The incumbent will interact with all site departments for GMP related operations and activities i.e. Manufacturing Operations Process Teams, Quality Control, Warehouse and Tank Farm teams and Engineering teams. In the event of quality or regulatory related issues, this position will interact with quality or regulatory representatives from drug product sites or Global Chemistry Manufacturing & Compliance (GCMC) teams.

**EDUCATION**
Bachelor Degree in Science/Chemical Engineering or equivalent.

**EXPERIENCE**
For QA Specialist: A minimum of 1 year experience in pharmaceutical industry or related industry is preferred.

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

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