Lead QC testing of raw materials, in-process samples, and finished products using HPLC, UV-Vis, dissolution, and stability studies while ensuring cGMP, WHO, and FDA compliance.
Manage instrument calibration, validation, troubleshooting, OOS/OOT investigations, and documentation per GLP/GDP/SOPs.
Supervise QC team, conduct audits, review batch records, and coordinate with QA/production for line clearances and CAPA implementation.
Implement quality improvements, stability programs, and regulatory submissions support, including method transfers and validation protocols.
Ensure lab safety, inventory management, and training on updated pharmacopeial standards (IP/USP/BP).

Preferred candidate profile

M.Pharm/B.Pharm with 5-10 years pharma QC experience, including 3+ years managing HPLC/UV labs for formulations; M.Sc Chemistry with equivalent experience acceptable. Expert in cGMP/GLP/ICH guidelines, stability testing, audits, and team leadership; Bengaluru-based preferred with export regulatory knowledge (e.g., Myanmar/Cambodia FDA). Analytical problem-solver with strong documentation skills and familiarity with ERP systems

More Jobs at Ce Chem Pharmaceuticals

Quality Control Manager

bengaluru

5.0 - 10.0 yrs

INR 5 - 8 Lacs

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Quality Control Manager