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.