Role & responsibilities

- Analytical Testing: Conduct routine/non-routine tests using HPLC, GC, UV-Vis, FTIR, Karl Fischer, and dissolution apparatus.
- Sampling & Release: Perform sampling of raw materials, packing materials, and finished products; issue Certificates of Analysis (CoA).
- Documentation: Maintain accurate records in LIMS/SAP systems, ensuring ALCOA+ compliance.
- Instrument Management: Operate, calibrate, and maintain analytical instruments per SOPs.
- Audit Readiness: Prepare evidence packs and ensure compliance with FDA, EMA, and CDSCO guidelines.
- Safety & Housekeeping: Follow EHS protocols, PPE usage, and maintain laboratory cleanliness.

Preferred candidate profile

- Strong knowledge of GMP/cGMP, ICH Q7Q10 guidelines.




- Hands-on expertise in analytical instrumentation (HPLC, GC, UV-Vis, FTIR).
- Proficiency in documentation systems (LIMS, SAP).
- Ability to conduct root cause analysis and support CAPA.
- Positive communication skills for cross-functional coordination with QA, Production, and Regulatory teams.
- B.Sc./M.Sc. in Chemistry, Pharmaceutical Sciences, or related field.
- 25 years of experience in QC within OSD formulation (tablets, capsules, granules).
- Prior exposure to regulatory audits (FDA/WHO/EMA) preferred.

📌 Quality Control Officer (Tarapur)
🏢 V S International
📍 Tarapur