04 Nov
|
Amulya Corporate Services
|
Vadodara
04 Nov
Amulya Corporate Services
Vadodara
Location: Vadodara
Department: Quality Control
Reports to: QC Manager / Head – Quality Control
Employment type: Full time | Experience: 2–5 years (injectable / sterile products experience mandatory)
Job Summary
We need a QC Officer with hands-on injectable (sterile / parenteral) experience to test raw materials, in-process, finished and stability samples in line with cGMP, GLP and data integrity requirements.
Key Responsibilities
- Analyse raw materials, packaging materials, in-process, finished and stability samples per approved specifications and STPs.
- Operate HPLC, GC, UV, FTIR, pH meter, osmometer and KF titrator; run injectable tests such as assay, related substances, particulate matter, pH, osmolality, clarity and extractable volume.
- Perform bacterial endotoxin (LAL) testing, support sterility testing, and analyse purified water and WFI.
- Follow cGMP,
GLP and ALCOA+; keep accurate records, logbooks and calibration schedules.
- Handle OOS / OOT and deviation investigations and support CAPA.
- Support internal audits and regulatory inspections (USFDA, EU GMP, WHO-GMP, CDSCO).
Required Qualifications
- B.Pharm / M.Pharm / M.Sc. (Chemistry or Microbiology).
- 2–5 years in QC of injectable / sterile products in a regulated plant (mandatory).
- Hands-on HPLC with Empower or ChemStation; working knowledge of LAL and particulate matter testing.
- Knowledge of IP, BP, USP, Ph. Eur. and ICH guidelines.
Pay: ₹300,000.00 - ₹400,000.00 per year
Benefits:
- Commuter assistance
- Flexible schedule
Work Location: In person
📌 QC Officer – Injectables (Vadodara)
🏢 Amulya Corporate Services
📍 Vadodara