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 strong 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 compliance applicable regulatory requirements.
13. Lead and support regulatory inspections and audits, including experience in handling USFDA and MHRA audits.
14. Ensure laboratory readiness for internal, customer, and regulatory audits.
15. Have sound knowledge of analytical method development and validation procedures for new chemical entities/new products.
16. Ensure analytical methods are appropriately developed, transferred, validated, and implemented in accordance with approved procedures and regulatory expectations.
17. Stay updated with applicable ICH guidelines and other relevant pharmaceutical regulatory requirements.
18. Drive continuous improvement in laboratory processes, analytical practices, compliance, and quality performance.

Required qualifications & skills

- Bachelor's or master's degree in pharmacy, chemistry, pharmaceutical chemistry, analytical chemistry, or a related discipline.
- Strong hands-on and managerial experience with HPLC, GC, dissolution, UV, and FTIR.
- Strong knowledge of CGMP, GLP, data integrity, laboratory investigations, OOS/OOT, deviations, and CAPA.
- Experience in analytical method development, method validation, verification, and transfer.
- Proven experience in handling USFDA and MHRA regulatory audits/inspections.
- Valuable knowledge of ICH guidelines and other applicable regulatory requirements.
- Strong leadership, people-management, problem-solving, investigation, and decision-making skills.
- Excellent documentation, communication, and cross-functional coordination abilities.

Key competencies Laboratory Management | Analytical Chemistry | cGMP Compliance | Regulatory Audits | Method Development & Validation | OOS/OOT Investigation | Deviation & Capa Management | Data Integrity | Team Leadership | Quality Systems

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