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QA Executive
ConfidentialGurgaon / Gurugram8 days ago
Job descriptionManage 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 above. Review and approve Deviation 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 by the job function. 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 between teams within QA and throughout facility. Assist with complaint investigations for internally produced commercial product. Ensure compliance to all compendial, internal and client-specific requirements (SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable). Ensure all work is performed and documented according to approved standard operating procedures, in general compliance with cGMPs and in a timely manner consistent with agreed upon schedules.
Skills Required
Sap, Capa, Sops
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