Posted:1 day ago|
Platform:
Work from Office
Full Time
Job Duties and Responsibilities (Please Mention In Below Table)
1 Manage release of product batches, including owning the QA product release workflow in SAP.2 Lead and supervise a team of QA professionals to perform operations as described above.3 Review and approve Deviation and Laboratory Investigations4 Review and approve Purchase Specifications and Analytical Standards5 Review and approve Issue Reviews and CAPA6 Assist with Non-Conformance Investigations and provide guidance in identifying potential product impactand determination of final product disposition7 Review and update Standard Operating Procedures (SOPs) for GMP compliance8 Follow all regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations asrequired by the job function Review validation protocols and completed documents, including processqualification protocols for validations of commercial processe9 Work to create an environment of open communication, participation and information-sharing within andbetween teams within QA and throughout facility10 Work to create an environment of open communication, participation and information-sharing within andbetween teams within QA and throughout facility11 Assist with complaint investigations for internally produced commercial product12 Ensure compliance to all compendial, internal and client-specific requirements (SOPs, Quality Agreements,General and Informational Chapters in multiple compendia as applicable).13 Ensure all work is performed and documented according to approved standard operating procedures, ingeneral compliance with cGMPs and in a timely manner consistent with agreed upon schedules
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