Job Description QC Manager (Sterile Injectables)

Responsible for managing Quality Control operations for sterile injectable pharmaceutical products, ensuring compliance with cGMP, regulatory requirements, and company quality standards. Lead laboratory activities, analytical testing, method validation, stability studies, investigations, and laboratory compliance while ensuring data integrity and timely product release.

Key Responsibilities:
Lead Quality Control laboratory operations for sterile injectable manufacturing.
Ensure compliance with cGMP, GLP, FDA, EU GMP, USP, Ph. Eur., JP, and BP requirements.
Oversee testing of raw materials, packaging materials, in-process, finished products, and stability samples.
Manage laboratory investigations, including OOS, OOT, deviations, and CAPA implementation.
Review and approve analytical data, specifications, test methods, protocols, and reports.
Supervise analytical method validation, verification, transfer, and troubleshooting.
Ensure qualification, calibration, and maintenance of laboratory instruments, including HPLC, GC, UV-Vis, TOC, and Dissolution systems.
Oversee environmental monitoring, water testing,



and microbiological quality programs applicable to sterile manufacturing.
Manage stability studies, reference standards, reagent control, and retention samples.
Ensure compliance with Data Integrity requirements (ALCOA+, 21 CFR Part 11, EU Annex 11) and maintain laboratory electronic systems such as LIMS.
Support technology transfer, process validation, recent product introduction, and regulatory submissions.
Lead internal audits, customer audits, and regulatory inspections, ensuring timely closure of observations.
Drive continuous improvement initiatives, laboratory efficiency, and development of QC personnel.
Collaborate with QA, Production, Engineering, and Regulatory Affairs to ensure timely product release and sustained compliance.
Hands-on experience with HPLC, GC, UV-Visible Spectrophotometer, Dissolution, TOC, LIMS, and laboratory computerized systems.
Experience in regulatory inspections, customer audits, and continuous improvement methodologies such as Lean or Six Sigma is preferred.

📌 Manager Quality Control Sterile Injectables Gujarat
🏢 Alembic Pharmaceuticals
📍 Gujarat