• Extensive data integrity and forensic review.
• Write Manufacturing, Laboratory and complaint investigations and recommend associated CAPA.
• Perform root cause analysis utilizing 6M, 5Whys and fishbone methodology.
• Review and approve CAPA and Investigation reports.
• In-process quality overview for in Aseptic Production area (MQA)
• Perform retrospective and prospective batch record review per established protocol.
• Perform analytical data review for QC chemistry.
• Create a training module and train laboratory data review teams.
• Quality review of ANDA.
• Conduct cGMP audit for compliance in production and laboratory.

• Collaborate cross-functionally with Quality, Maintenance, Warehouse, and other production personnel to ensure information is properly shared and production remains on schedule. Identify process improvements and support continuous improvement initiatives.

failures. This may include investigation of Production, Incoming Quality, Chemistry, Microbiology, Engineering, Validation, and other personnel necessary to complete the investigation. Conduct personnel interviews and system reviews. Act as an unbiased investigator with questions surrounding the specific issue.
• Evaluate corrective actions regarding trends. Identify and implement preventive actions to eliminate the potential for non-conformities to occur.
• Track the progress of all investigations as they pertain to Exception Reports/Quality Assurance Reports. Report progress in the weekly department meetings and Product Flow Optimization (PFO) meetings.

• Primary quality contact for production personnel.
• Monitor production processes for compliance to cGMP standards.