05 Nov
|
Amulya Corporate Services
|
Vadodara
05 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
Advantages:
Commuter assistance
Adaptable schedule
Work Location: In person
📌 Qc Officer – Injectables Vadodara
🏢 Amulya Corporate Services
📍 Vadodara