Monitoring for Documents compilation activities for New product filing , Re-Registration, renewals from plant dossier filing , sample requirements etc. Participation in Action plan discussion for queries from different Regulatory agencies and monitoring for submission of data/documents from plant.
B.Pharm, M.Pharm ; Granulation, Compression, Coating, FBE, Capsule Hard Gelatin and Soft Gelatin, Blister Packing Primary and secondary for Cytotoxic, Sex Hormones
General injectable, Sex Hormones, Cyto Parenteral, SKID, QMS, GMP Documentation. Sun Pharma is the fourth largest specialty generic pharmaceutical company in the world.
Sun Pharmaceutical Medicare Limited is taking this opportunity to balance employment and the medications for the world. Batch Manufacturing Record, BMR Requisition, BMR Issuance Logbook.
Must have excellent skills and knowledge of bioanalytical sample processing techniques. Very good understanding of current bioanalytical guidelines of various regulatory agencies such as USFDA, ANVISA, ICH etc.
Assist in developing global Pharmacovigilance system auditing program and responsible for conducting and reporting audits being a lead auditor, co-auditor for outsourced parties CROs, Service Providers, Vendors, Affiliates & Partners etc., associated with Sun Pharma