Job Description

Title:

Executive - Quality Control - Investigator

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Date: May 19, 2025
Location: Dadra - Quality Control
Company: Sun Pharmaceutical Industries Ltd

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.