Quality & Compliance Audit Manager
1 month ago
Our global pharmaceutical client is looking for a Quality & Compliance Audit Manager to join their team. The successful candidate will effectively communicate audit findings using established processes and methodology.
Responsibilities:- Follow SOPs for External and Internal audits and support the Global audit program.
- Plan, execute, and report quality audits for GMS, High-Risk Suppliers, Contract Service Providers, and assigned qualifications.
- Maintain ETS records, interface with audit requestors, and update audit status promptly.
- Write timely audit reports, notify management of Critical Findings or high-risk auditees, and distribute reports.
- Follow up on CAPA plans, manage outsourced audits, and provide support for inspections.
- Offer technical expertise, conduct Mock PAI and inspection readiness assessments.
- Train and support auditors/site auditors in ETS usage and processes.
- Provide training for 3rd party auditors on contract audits.
- Lead designated projects as assigned by management.
- Bachelor's Degree in Science, Engineering or equivalent.
- At least 8+ years experience within Quality in the pharmaceutical industry.
- Demonstrated GMP/GDP audit experience.
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