Pfizer Team Associate in Chennai, India

  • Execution of internal audit program at site and ensuring its compliance with all appropriate regulations and standards.

  • Perform walk-through audits of all GMP operational areas in compliance with internal audit program

  • Prepare, review of procedures, audit schedules/plans, audit reports, audit responses, and other documents.

  • Review and Approval of audit response, Corrective actions, Preventive actions, Effectiveness verification and all other relevant records pertaining to Internal Audits.

  • Escalate issues to Internal Audit Lead, Compliance head and Site Head - Quality Assurance as appropriate.

  • Ensure the compliance with all gQTS requirements Commitment Tracking (CT), Manufacturing Investigation (MIR) and other modules as applicable.

  • Imparting training on gQTS Commitment tracking modules to all the concern personnel

  • Participation in Regulatory and other external inspections as applicable.

  • Preparation of Corporate, Regulatory, Customer inspectional observation responses in co-ordination with Cross functional team members.

  • Preparation and Review of the Proof books for the Regulatory, Corporate and other inspections as applicable.

  • Perform Gap Assessments to other site regulatory inspectional findings and Current regulatory standards/Guidance/Updates/ Corporate Standards as applicable.

  • To provide required support to the team and ensure ATR (All Time Readiness) of site for smooth handling of Audits.

  • Preparation and submission of relevant data/information for SQRT (Site Quality review team) meeting.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.