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)
🏢 Immacule Life Sciences
📍 Nalagarh