TARUN BISWAS, Manager – Quality and Compliance (Pharmacovigilance), Ipca Laboratories

The best kind of experience in Quality Management Systems for manufacturing of Pharmaceuticals formulations for a wide range such as Solid Dosage Forms (Tablets, Capsules), Liquids, Powder, Injectables, Ointments, Cosmetics, Packaging, etc.. in Quality Assurance. Specialties: Validation, GMP, GLP, Qualification, Quality Compliance, Quality Control, Deviation & Change Control, CAPA, Handling product quality complaints and market complaints, Good Documentation Practices, Global reporting, regulatory as per USFDA, ANVISA, MHRA, MCC, TGA, WHO GMP, CDSCO, NDA, MCC, Quality Management Systems and tools.

Currently in Pharmacovigilance/Drug Safety, Strong Knowledge with cross-functional expertise in regulatory, safety, and quality, information management in Pharma Environment for USFDA, EU MHRA, EMA, PvPI-CDSCO, Medical Literature Monitoring, ICSRs, Embase, Pubmed, ASPR's, ARISg5, Argus 6.0/7.0/8.01/8.1.2, PSUR, PBRER, PADER, SPC, RMP, Eudravigilance, XEVMPD, GxP, assistance to QPPV, PSMF, PRAC, WHO, PvPI, CDSCO, Training, Documentation, Trackwise, LMS, QMS, Medico Regulatory Affairs, Audits, and Regulatory compliance monitoring, Post Market Surveillance, Regulatory Strategy. Also a good thinker.