Position: Drug lab incharge

Experience: 12+ years of relevant experience in managing a pharmaceutical quality control/analytical laboratory.

Desirable experience : Through knowledge of the requirements of US-FDA and other regulatory agencies

Job summary

We are looking for an experienced Drug Lab Incharge to lead and manage the laboratory operations, ensuring accurate, reliable, and timely analytical testing in compliance with regulatory bodies. The candidate should have solid expertise in analytical techniques, laboratory quality systems, investigations, validation, and regulatory audits.

Key responsibilities

1. Lead, mentor, and manage laboratory personnel, ensuring effective team performance and development.
2. Manage day-to-day laboratory operations and allocate tasks to the laboratory team.
3. Ensure adequate training of laboratory staff on analytical techniques, laboratory procedures, safety, and CGMP requirements.
4. Oversee testing of raw materials, in-process samples, finished products, and other relevant samples.
5.



Ensure proficiency in analytical techniques including HPLC, LCMS, GC, dissolution, UV-visible spectrophotometry, and FTIR.
6. Develop, review, and approve sops, analytical test procedures, specifications, and quality plans.
7. Investigate and resolve deviations, incidents, OOS/OOT results, and customer complaints related to laboratory/qc activities.
8. Ensure the accuracy, integrity, and reliability of analytical data through proper control of reference standards, working standards, reagents, and laboratory records.
9. Manage and monitor the CAPA process for qc-related issues and ensure timely and effective implementation.
10. Ensure complete and accurate documentation of all laboratory activities, including raw data, analytical results, calculations, and reports.
11. Prepare, review, and approve analytical method validation/verification protocols and reports.
12. Establish, implement, and maintain laboratory quality systems to ensure com

📌 Drug Lab Incharge (New Delhi)
🏢 SHRIRAM INSTITUTE FOR INDUSTRIAL RESEARCH
📍 New Delhi