Role & responsibilities
Lead end-to-end QC laboratory operations, including testing of raw materials, packaging materials, in-process samples, bulk and finished products.
Oversee analytical testing of sterile injectable products, including liquid injections, lyophilized products, PFS and ophthalmic preparations, as applicable.
Review analytical data, chromatograms, raw data, specifications, SOPs, protocols and laboratory reports.
Ensure compliance with cGMP, USFDA, EU GMP, ICH guidelines, applicable pharmacopoeias and data integrity requirements.
Lead OOS/OOT investigations, laboratory deviations, incidents, root-cause analysis and CAPA implementation.
Manage stability studies, analytical method validation, method transfer and validation-related testing.
Ensure qualification, calibration,



maintenance and compliance of laboratory instruments and computerized systems.
Ensure inspection readiness and support regulatory inspections, customer audits and internal audits.
Manage QC manpower, training, competency development, workload planning and laboratory performance.
Monitor testing turnaround time, investigation closure, documentation compliance and laboratory efficiency.
Coordinate with QA, Production, Microbiology, Engineering and other relevant functions to resolve quality issues and ensure uninterrupted operations.

Preferred candidate profile

📌 Senior Manager Quality Control Sterile Injectable Nalagarh (India)
🏢 Immacule Life Sciences
📍 India