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Senior Associate, Qa Operations
Conduct thorough investigations of deviations to ensure product quality and compliance.
Mississauga, Ontario, Canada
Senior
1 week ago
Resilience
Protecting organizations against digital threats and vulnerabilities.
Job is no longer active
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✨ About The Role
- The Senior Associate in QA Operations will be responsible for overseeing QA activities related to clinical and commercial manufacturing.
- The role involves batch record review, investigations, and product disposition to ensure compliance with regulatory standards.
- The candidate will provide on-the-floor support in manufacturing and fill finish areas, performing audits and checks on production activities.
- The position requires participation in batch readiness and scheduling meetings, as well as timely room release and change-over approvals.
- The individual will also assist in the investigation of deviations and evaluate the appropriateness of CAPA measures.
âš¡ Requirements
- The ideal candidate will have extensive experience in Quality Assurance within a biomanufacturing or pharmaceutical environment.
- A strong understanding of GMP compliance and regulatory requirements, including those from the US FDA, Health Canada, and EU standards, is essential.
- The candidate should possess excellent analytical skills to assess the impact and criticality of production events and deviations.
- Experience in conducting investigations and root cause analysis for non-conformances is crucial.
- The successful individual will be proactive in supporting production activities and ensuring quality oversight on the manufacturing floor.
Senior Associate, Qa Operations
Mississauga, Ontario, Canada
Strategy & Ops
Job is no longer active
About Resilience
Protecting organizations against digital threats and vulnerabilities.