QA Project Manager
We are seeking an experienced QA Project Manager to provide coverage for a 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 is essential.
* A strong understanding of Quality Management Systems (QMS), including deviations, CAPAs, change controls, and batch disposition processes is crucial.
* Excellent communication and cross-functional collaboration skills with the ability to interface with internal teams and external customers are required.
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Key Responsibilities
* Quality Operations & Documentation:
Review and approve deviations, change controls, CAPAs, SOPs, batch records, and GMP documents to ensure compliance. Support and represent QA during audits and inspections to maintain a high level of quality.
* 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 to ensure timely completion.
* Customer & Batch Release Interface:
Manage QA-related customer interactions, such as OOS, complaints, changes, support batch disposition activities, and act as delegate for the FvP for conditional release to maintain strong relationships with customers.
About Coopers iET AG
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