3-4

The candidate should actively participate in addressing lab incidents and deviations. Additionally, exposure to regulatory documentation requirements and a solid understanding of cGMP and GLP are crucial.

PhD, MS, BS in relevant functions in the Pharmaceutical, Biotechnology Industry, or equivalent. Subject matter expertise in regulatory affairs and related activities.

Glenmark Pharmaceuticals Limited is a research‐led, global pharmaceutical company, having a presence across branded, generics, and OTC segments; with a focus in the therapy areas of Respiratory, Dermatology and Oncology.

Experience in production planning, change control, line clearance, deviation handling, autoclave operation TS and component, aseptic & controlarea operation, documentation, both SVP and LVP manufacturing etc.

Work closely with cross-functional teams including preclinical, clinical, and regulatory teams to guide decision- making and project direction. Utilize software tools such as WinNonlin, R, SAS, Matlab, Monolix, GastroPlus Simcyp, PK-Sim, and other similar platforms for M&S.

Having Injectable Experience of Shop floor ac-tivities like vial washing, compounding, filtration, filling and Sealing, Autoclave, Garment Washing machine, Lyophilizes

Must be from Formulation Industry. Undertake method development, troubleshooting and method validation to GMP and ICH. Investigation of non- conforming samples, CAPAs, data evaluation and reporting.

Ph.D., Masters degree, Bachelors Degree with First class in all the preceding degrees in the appropriate branch, with an exemplary academic record throughout.

Experience in oral solid dosage Manufacturing, CVC Packaging. Exposure to Granulation, Compressioa Cooting and Bottle Packaging.