Senior Executive-QA

Overview

Senior Executive in Quality Assurance at a CDMO's Ahmedabad site, supporting GMP document control, sampling, batch record review and the Quality Management System in the Pilot Plant.

What you'll do

• Issue and control GMP documents, including SOPs, BMRs, BPRs, formats, logbooks and LNBs.
• Manage the archival and retrieval of documents.
• Monitor temperature for retention sample storage.
• Perform in-process sampling of clinical batches, swab sampling during cleaning verification, and water sampling.
• Carry out line clearance in the pilot plant and manage control samples.
• Review master and executed Batch Manufacturing Records, Batch Packaging Records and other manufacturing and packaging documents.
• Ensure Pilot Plant practices comply with site quality procedures.
• Prepare SOPs for the QA department.
• Deliver induction training on relevant topics.
• Update logbooks for QMS documents, including change control, deviations and OOS.
• Ensure compliance with and awareness of data integrity across the site.