31 Jul
|
The Pharma Patashala
|
Andhra Pradesh
31 Jul
The Pharma Patashala
Andhra Pradesh
Quality Control (QC HPLC, GC & Stability) | Experience: 2–6 Years
Roles & Responsibilities
- Perform analysis of Raw Materials (RM), In-Process (IP), Finished Products (FP), and Stability samples using HPLC, GC, UV, Dissolution, and KF.
- Operate, calibrate, and troubleshoot HPLC, GC, and other analytical instruments.
- Prepare mobile phases, reagents, standard solutions, and test samples as per SOPs.
- Review chromatograms, calculate results, and ensure compliance with specifications.
- Conduct stability testing as per ICH guidelines and approved stability protocols.
- Perform instrument calibration, qualification, and preventive maintenance activities.
- Investigate OOS, OOT, deviations, and laboratory incidents, and support CAPA implementation.
- Maintain laboratory documentation, logbooks, and analytical records in compliance with cGMP, GLP, GDP,
and ALCOA+ Data Integrity.
- Participate in method verification, method transfer, and analytical method validation activities.
- Coordinate with QA, Production, and Regulatory teams for sample analysis and timely release.
Required Skills
- 2–6 years of QC experience in the pharmaceutical industry (API/Formulation).
- Hands-on experience with HPLC, GC, UV, Dissolution, KF, pH Meter, and analytical balances.
- Knowledge of ICH Guidelines, cGMP, GLP, GDP, ALCOA+, OOS, OOT, and CAPA.
- Experience with chromatography software such as Empower, Chromeleon, or LabSolutions.
- Solid analytical, documentation, troubleshooting, and communication skills.
📌 Quality Control Officer (Andhra Pradesh)
🏢 The Pharma Patashala
📍 Andhra Pradesh