Role Summary
Accountable for effective management of Quality Control documentation related to batch certification and QMS records involving Quality Control.
Key Responsibilities
1. Support, manage, and coordinate across Quality Control teams for the completion of QC QMS records, including Deviations, CAPA, Change Controls, Effectiveness Checks, EME, OOX Phase 2, and Discrepancy reports.
2. Ensure timely progression and closure of QMS and batch records.
3. Lead Quality Control investigations and root cause analysis, obtaining support from other business stakeholders when required.
4. Liaise with Quality Control management for proposed CAPA agreements.
5. Act as the Quality Control point of contact for Quality Assurance.
6. Ensure Quality Control QE certification readiness.
7. Define, record, and communicate Quality Control metrics to GMP Council.
8. Manage cross-functional stakeholder relationships, liaising with a wide range of supporting functions including Quality, Training, Engineering, MSAT, Validation, supply chain, and OPEX.
9. Build and own Quality Control record tracking systems and report to QA and SLT.
10. Define, develop, and communicate PDN metrics.
11. Lead documentation improvements and updates, liaising between QC, MSAT, ASAT, and QA.
12. Lead, prioritize, and execute multiple activities across span of control, covering safety, quality, supply, people, and continuous improvement deliverables.
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