5+

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.

The individual has experience in handling various analytical techniques such as such as HPLC, GC, CE-SDS, SEC, ELISA, qPCR, DSC, Bioassay, Karl Fischer, UV, LC-MS, Dissolution, Disintegration, X-ray diffraction, etc.

To review and assess data based on Analytical QBD based approach. To ensure analytical development data supports to robust test method and suitable to entire product lifecycle.

Cliantha Research, a full-service Clinical Research Organization, is a leading provider of Clinical research services, based in Ahmedabad, India.