5+

Hands on experience in developing and manufacturing different types of enabling and novel formulations for improving the bio-pharmaceutical properties and bioavailability of New Chemical Entities

M. Pharm with 10 years of experience in handling ADME assays and HPLC and LCMS, MS Or Fresh Ph.D. in similar disciplines

To perform line clearance activity before starting of different operations like dispensing, manufacturing, filling, inspection, sealing, labeling & packing.

Person should know QMS, IPQA, validation, Qualification, Cleaning Validation, Risk Assessment, CSV, regulatory requirements, Market Complain, Vendor Qualification, OOS, OOT, Product Recall, Investigation, Regulatory requirement, audit & response.

M.Sc, M.Pharma, B.Pharma. Working in QC analyzing, Stability. In process. FP. RM sample. Handling instruments like HPLC. GC. FTIR. UV, DR. SSA. etc. versatile In handling SAP. documentation like preparing STPs and review of analytical hard copies and electronic data.

Granulation, Coating, Compression, Bottle Packing Machine Exposure, RMG, FBE, FETTE, Autocoaters /Bottle Packing line with track and trace system. To supervise and monitor day to day activities of processing and holding of drug product as per define and approved procedures for stability batches and commercial batches.

Looking to hire Head Of Regulatory Affairs - an aggressive, dynamic Regulatory Affairs Professional. Who would assume the Regulatory strategic, filing and post approval life cycle management and Quality, Technical and regulatory compliance responsibilities as per EU, UK, USA, and PIC, s requirements.

Experience in API Production, Bulk Drug, API Production To be responsible for Batch start up activity, monitoring, calibration of balance and other instruction given by the Superior, Should have exposure in reactors, centrifuges, and a clean room equipped with sound knowledge in cGMP and SOPs.

proven work experience in Regulatory Affairs in the Pharmaceutical or Healthcare, or organizations in other regulated sectors. The incumbent is also responsible for acting in compliance with country policies and practices to reduce Takeda exposure to regulatory risks as well as for developing the local Regulatory team as appropriate.