Executive - Quality Control - Investigator
2 days ago
**Title**:Executive - Quality Control - Investigator**:
- Date: May 19, 2025
- Location: Dadra - Quality Control
- Company: Sun Pharmaceutical Industries Ltd
**Job Summary**:
**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.
**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.
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