Description
The successful candidate will assure cGMP compliance with applicable regulatory requirements including audits and documentation review. The candidate will also need minimum of 5 years experience within the GMP Pharmaceutical field.Primary Duties and Responsibilities- Represents and interfaces with Pharmaceutical Sciences and Regulatory Affairs to provide Good Manufacturing Practices guidance in an effective manner.
- Reviews production batch records and associated data for product release; determines if records are within range of cGMP regulations.
- Reviews Analytical Certificate of Analysis data packages for compliance with approved methods.
- Archive and file QA documents.
- Maintain vendor files and track and trend vendor deviation/out of specification and non-conformance events.
- Develops, revises and reviews Standard Operating Procedures.
- Reviews equipment calibration and qualification documents to ensure compliance with internal procedures and manufacturer performance specifications.
- Trouble-shoots and takes the initiative on any QA-related issue for GMP compliance.
- Reviews protocols, study reports, etc. for product release and method validation; ensures that no deviations from approved protocols were made without proper authorization/documentation were performed in accordance with the GMP guidelines.
- Carry out job responsibilities and assignments safely and maintain a clean and safe work area.
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Bachelor's (BS) or higher in the Life Sciences or related discipline.
To find out more about Real please visit www.realstaffing.com