Self-driven professional offering nearly 21 years of experience in API (Oncological) Production
Last assignment as Senior Manager – Production with Fresenius Kabi Oncology Limited; Kalyani Unit, West Bengal –Bulk Drug Manufacturing Plant; managing production of Oncological API (Paclitaxel, Docetaxel, Irinotecan Hydrochloride, Busulfan, Pemetrexed diacid, Bendamastine) including purification process of Column Chromatography as well as various types of solvent based purification
Pioneering experience in managing technically advanced, cost-efficient and state-of-the-art production systems; skilled in enhancing productivity, improving operational efficiency, quality & process effectiveness and achieving cost reduction
Hands-on experience in preparation & review of SOP, batch records, validation and qualification documents; skilled in utilizing ERP packages including SAP, LIMS, DMS and Trackways system
Managed cross-functional operations in investigating of Deviation, OOS (Out-of-Specification), OOT/OOE (Out of trend/Out of Expectation) Market complaints and evaluation of Impact/Risk Assessment to identify the appropriate root causes and CAPAs and checking of effectiveness
Possess sound expertise in implementing inspection, testing, material evaluation, components or assemblies as per stipulated schedule and quality aspects to identify the lacking characteristics without destroying the serviceability of the part or system
Proficient in following risk management approach in QMS policies, strategies, procedures & practices; devised an appropriate mechanism to detect risk to products and took expeditious for its containment
Excellent track record of leading large sized teams and achieving best performance in large scale factories
Gained experience in working on CTS approved by West Bengal Government Drug Controller
