QA Project Manager
We are looking for a proactive and experienced QA Project Manager to provide coverage for maternity leave in our client's Drug Product QA team. This role offers a broad scope across quality operations, compliance oversight, and project-based QA support, with strong interaction across Manufacturing, QC, and Engineering teams. The successful candidate will be responsible for ensuring GMP compliance, supporting audits, driving quality system improvements, and acting as a key QA contact for project and customer-related activities.
Key Requirements (Must-Haves)
- Solid experience in a GMP-regulated environment, ideally in QA roles within drug product manufacturing
- Strong knowledge of Quality Management Systems (QMS), including deviations, CAPAs, change controls, and batch disposition processes
- Excellent communication and cross-functional collaboration skills with the ability to interface with internal teams and external customers
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Key Responsibilities
- Quality Operations & Documentation:
Review and approve deviations, change controls, CAPAs, SOPs, batch records, and GMP documents. Support and represent QA during audits and inspections.
- Project-Based QA Oversight:
Act as the QA point of contact for manufacturing projects, reviewing risk assessments, protocols, transfer documents, and providing disposition recommendations to the FvP.
- Customer & Batch Release Interface:
Manage QA-related customer interactions (e.g., OOS, complaints, changes), support batch disposition activities, and act as delegate for the FvP for conditional release.