Role & responsibilities
- Chromatography Supervision: Oversee routine testing, troubleshooting, and calibration for HPLC, UPLC, and GC systems using software like Empower 3.
- Regulatory Compliance: Enforce ALCOA+ data integrity guidelines, review electronic audit trails, and actively defend the lab during USFDA/MHRA audits.
- QMS & Investigations: Lead scientific investigations for OOS (Out of Specification), OOT (Out of Trend), deviations, and implement robust CAPAs.
- Documentation: Draft and approve SOPs, Standard Testing Procedures (STPs), specifications, and method validation protocols.
- Team Leadership: Manage daily testing workflows, allocate analysts to shifts, and provide technical coaching.
Preferred candidate profile
Preferred Candidate Profile for an Lead (HPLC/GC) in a USFDA-approved API plant
📌 Assistant Manager - QC HPLC/GC (Tarapur)
🏢 IPCA
📍 Tarapur