Assistant Quality Assurance Manager

• Responsible for the site Validation program.
• Ensures Validation Master plan, IQ, OQ, PQ and PV for products and equipment are written, executed and reviewed.
• Develops and reviews SOPs for the sites and ensure training is complete for SOP implementation.
• Reviews and approves new and revised Master Batch Records
• Assist with Batch Record review activities and final product release, as needed
• Investigates and troubleshoots product and production issues on laboratory scale and manufacturing batches
• Writes and reviews LIRs, IRs and CAPAs for the site with appropriate tools to prevent future recurrence of errors.
• Writes and reviews stability reports.
• Review change controls as needed.
• Manages Quality Assurance personnel and provides instruction and guidance when personnel/production issues arise.
• Reports issues immediately to Quality and Operations upper management.
• Work closely with Production to ensure the oversight and maintaining of cGMP documentation and processes
• Recommend measures to maintain safe operations, improve production methods, equipment performance and use of equipment to increase efficiency, quality and safety of the production floor
• Ensure compliance with Internal, Federal, State and local guidelines and regulations including cGMP, OSHA, and FDA.
• Other duties as assigned