3-4

Knowledge of microbiological testing, environmental monitoring, water system analysis, HVAC validation, QMS. Able to carry in-process checks, line-clearance, knowledge of track & trace system, issuance of protocols, logbooks, BMR & BPR

Candidate should have strong understanding of OSD manufacturing processes and knowledge of cGMP and relevant regulatory requirements. Monitoring critical process parameters during manufacturing. Candidate should have sound knowledge of QMS - Incidents, Change control, Deviations etc. Should be able to handle the team of 8-10 persons

Intas is one of the leading multinational pharmaceutical formulation development, manufacturing and marketing companies in the world.

Planning and performance of Validation, Verification of analytical methods as per the relevant procedures, protocols. Experience in Handling of GC, HPLC, IC, UV instruments with Lab solutions, Empower, Chromelon, Magic net software and experience on LIMS.

Compression, Coating, Capsule Filling, FBP. QC Microbiology, IP/FP, Stability, GLP,RM. QA IPQA, AQA, APQR.

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.