QA Specialist

The incumbent is a member of the Quality Assurance team. Under the supervision of the Senior Compliance Manager, the incumbent will be responsible for the following:
- Drive quality culture and promote GMP compliant behaviours at the site.- Ensure site compliance to Pfizer Quality Standards (PQS) and ICH guidelines.- Provide quality oversight to vendor management to ensure production materials used meet Pfizer Quality Standards (PQS).- Work with GCMC to file products and address regulatory queries in an accurate and timely manner.- Ensure site inspection readiness and responsible for management of logistics for internal and external GMP inspections.- Collaborate with cross functional teams to improve quality systems.- Contribute to achieve our vision of being best in class manufacturing site, producing highest quality products in the safest way.

POSITION RESPONSIBILITIES

**Responsibilities**:
- Review and approve GMP documentation to ensure their compliance with PQS.- Qualify and manage vendors according to PQS and maintain accurate records of vendor status. Review and analyze the quality related issues from vendors and recommend improvement actions to mitigate compliance risks. Ensure vendors and materials are qualified as required to support production schedule.- Conduct internal audits to ensure internal controls are effective. Conduct external audits to ensure adequate oversight to vendors and collaborate with vendor to reduce material quality issues.- Manage logistics for internal and external GMP inspections, including site communications and training.- 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.- Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner.- Ensure gap analysis of site procedures against PQS is performed by relevant SMEs in a timely manner meeting requirements for rollout of new / updated PQS / Policy Memos.- 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.- Support preparation and/or coordination of site monthly and adhoc Site Quality Review Team (SQRT) meetings.- 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.

ORGANIZATIONAL RELATIONSHIPS

The incumbent will interact with all site departments for GMP related operations and activities e.g. Manufacturing Operations Process Teams, Quality Control, Supply Chain, Engineering, New Production Introduction and Technical Services teams as well as above site teams (e.g. PQS SMEs). For vendor management, inspection / regulatory related issues, this position will interact with quality or regulatory representatives from drug product sites, corporate groups or Global Chemistry Manufacturing & Compliance (GCMC) teams and material / GMP service vendors.

EDUCATION- Degree in Chemistry, Microbiology, Engineering or other Science related discipline.

EXPERIENCE- Minimum 1 year experience within the pharmaceutical industry.- Strong written and oral communication skills.

Work Location Assignment: On Premise

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