Title:  Executive - Quality Control - Investigator

Job Summary:

We are seeking an experienced and detail-oriented QC Investigator to join our Quality Control team. The role involves leading and supporting laboratory investigations including OOS (Out of Specification), OOT (Out of Trend), and other lab-related events, ensuring timely identification of root causes, and implementation of effective CAPAs. The ideal candidate will bring in-depth technical expertise, investigative acumen, and strong documentation and communication skills.

Key Responsibilities:

• Lead and conduct thorough investigations of OOS, OOT, and laboratory events in compliance with cGMP and regulatory standards.
• Perform root cause analysis (RCA), develop hypotheses, and ensure correctness and scientific soundness of the investigations.
• Define and implement Corrective and Preventive Actions (CAPAs), verify their implementation, and evaluate effectiveness.
• Draft high-quality investigation reports with clear, concise, and scientifically justified conclusions.
• Trend and analyze OOS/OOT/lab event data to identify recurring issues and opportunities for process improvement.
• Actively participate in troubleshooting laboratory instruments and equipment.
• Maintain proficiency in operation and troubleshooting of a wide range of laboratory instruments (e.g., HPLC, GC, UV, IR, etc.).
• Review and enhance existing QC systems and practices to drive continuous improvement and ensure regulatory compliance.
• Collaborate cross-functionally with QA, production, and other departments during investigation and resolution processes.
• Participate in audits and regulatory inspections as a subject matter expert for laboratory investigations.

Desired Candidate Profile:

Education: M.Sc. / B.Pharm / M.Pharm or equivalent in a relevant scientific discipline.

Experience: 7–10 years of experience in pharmaceutical QC, with strong exposure to laboratory investigations.

• Solid understanding of cGMP, ICH guidelines, and regulatory expectations.
• Strong technical writing and communication skills.
• Proficiency in data analysis and trending of lab events.
• Hands-on experience with QC instruments and troubleshooting.