• To ensure timely and thorough investigation of quality-related events such as deviations, OOS, and OOT results in compliance with regulatory standards and internal SOPs, thereby maintaining product quality and patient safety.

• Deviation Handling:
  • Initiate and lead investigations for laboratory and manufacturing deviations.
  • Identify root causes using tools like 5 Whys, Fishbone, or CAPA analysis.
  • Collaborate with cross-functional teams to implement corrective and preventive actions (CAPA).
• OOS Investigations:
  • Conduct Phase I and Phase II investigations for OOS results.
  • Review analytical data, equipment logs, and analyst performance.
  • Coordinate retesting and reanalysis as per SOPs.
  • Document findings and ensure regulatory compliance (e.g., MHRA, FDA).
• OOT Investigations:
  • Monitor data trends and identify atypical results.
  • Investigate potential causes for OOT results and assess batch impact.
  • Recommend actions to prevent recurrence.
• Documentation & Reporting:
  • Prepare detailed investigation reports with evidence and conclusions.
  • Maintain records in compliance with Good Documentation Practices (GDP).
  • Present findings during audits and regulatory inspections.
• Compliance & Training:
  • Ensure investigations align with cGMP, ICH and regulatory expectations.
  • Train QC analysts on investigation procedures and data integrity.

M.SC/B.Pharma

3 to 10 years