Job Description
- Manage release of product batches, including owning the QA product release workflow in SAP.
- Lead and supervise a team of QA professionals to perform operations as described.
- Review and approve Deviations and Laboratory Investigations.
- Review and approve Purchase Specifications and Analytical Standards.
- Review and approve Issue Reviews and CAPA.
- Assist with Non-Conformance Investigations and provide guidance in identifying potential product impact and determination of final product disposition.
- Review and update Standard Operating Procedures (SOPs) for GMP compliance.
- Follow all regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations as required.
- Review validation protocols and completed documents, including process qualification protocols for validations of commercial processes.
- Work to create an environment of open communication, participation, and information-sharing within and...
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