QA Batch Record review consultant
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Global Compliance Partners (GCP) is a GxP and GMP compliance consulting firm with over a decade of experience supporting biopharma and cell & gene therapy organizations. We partner with leading drug developers and manufacturers to deliver validation, quality, and compliance solutions, from QC, QA, CSV/CQV and process validation through tech transfer and BLA support. Our consultants embed directly with client teams to move programs forward with rigor and speed
We are looking for QA consulants with experience in QC/Analytical batch record review and lot disposition/release experience within pharmaceutical manufacturing. Experience reviewing completed analytical batch records and associated Quality documentation, identifying documentation issues or discrepancies, and working with Quality and Manufacturing to resolve issues prior to release. Sterile/aseptic pharmaceutical manufacturing experience preferred.
Scope of Work
- Perform comprehensive, end-to-end review of completed analytical batch records and associated documentation for completeness, accuracy, consistency, and compliance with applicable procedures and GMP requirements.
- Review the entire manufacturing batch record package and Analytical data package, including manufacturing and lab documentation, supporting records and applicable Quality documentation required for lot disposition and release.
- Identify documentation errors, discrepancies, missing information, or other issues that may impact batch disposition or release.
- Work with appropriate Curia personnel to facilitate resolution of identified issues and obtain required corrections or supporting documentation.
- Confirm that required documentation and Quality requirements have been satisfactorily addressed prior to lot disposition and release.
- Support final lot disposition and release activities in accordance with Curia procedures and established Quality requirements.
- Maintain appropriate documentation of review activities and communicate status, issues, and potential release constraints to Curia Quality leadership.
Desired Experience
- Strong pharmaceutical GMP batch record review and lot disposition/release required.
- QC/Analytical lab experience strongly preferred.
- Ability to perform comprehensive review of completed batch records and associated Quality documentation.
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