Quality Assurance Manager

Pfizer Ltd. Indonesia (Jakarta JK, Indonesia) 4 days ago

Work Location: Pfizer Global Supply Jakarta, Indonesia

Worker type: Permanent / Regular

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. Pfizer Indonesia is looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

Role Summary:

The primary purpose of this position is to provide leadership and direction to the Quality Assurance (QA) team. The role will own the responsibility for ensuring that all processes in QA team, batch record evaluation and review, release / rejection of finished goods for distribution, manufacturing investigation,  product quality complaint investigation, notification to management are remain compliant with site procedures and regulatory requirements, reliable and effectively performed, and ultimately that the team deliver on their commitments. 
 

The role is the back-up person for QA Release Supervisor in finished product disposition and approval of regulatory related filing document.  As manager at PGS Jakarta, keeping your team engaged, focused and aligned on key site priorities will be fundamental to your success.

Role Responsibilities:

  • Maintain and ensure compliance in Quality and Safety such as submitting CASR, QAR, and CAPA as per committed in QA team.
  • Responsible for ensuring that PGS Jakarta delivers on customer expectations of supplying quality Sterile and Non- sterile products. Finished product disposition schedule adherence against the Production Plan is critical.
  • Responsible for ensuring that batch record review of Sterile and Non Sterile products manufactured by PGS Jakarta including 3rd party products, and also batch record review of packaged import product is done in compliance with Site Procedures and Regulatory Requirements. Schedule Adherence against the Production Plan and Shipment Plan is critical.
  • Manage effective all processes in QA and ensure they are conducted in a safe and compliant work environment.
  • Drive team engagement, effective communication, and the development of supervisors within the QA team.
  • Lead for the preparation of regulatory, customer and Pfizer global audits for the QA team.
  • Continuously monitor Key Performance Indicator (KPI) in QA team and provide coaching and feedback as required.
  • Manage and coordinate manufacturing investigation and product quality complaint investigation to ensure timely completion of investigation, including the notification to management and notification to 3rd party, batch record evaluation and review and release / rejection of finished goods for distribution activities to ensure timely product supply.
  • Drive team engagement and effective communication within the QA team.
  • Actively coordinate with the teams to ensure the projects (i.e., CIP, Operational Excellence, Innovation projects etc.) in QA release team are delivered in the most effective way

#LI-PFE

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
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