Halol

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.

Granulation, Compression, FBE, Cyto, Sex Hormones Blister Packing - Primary, Capsule Hard Gelatine and Soft Gelatine.

Hands on Experience for handling critical lab instruments like HPLC, GC, Dissolution, UV Spectrophotometer, LIMS, FTIR , experience in Analysis of RM, FP and IP stability in QC.

Water and Bioburden Testing and Microbiological limit testing, Sterility Testing and BET Testing, IQ,OQ and PQ of equipment, Trend Analysis preparation, Biological reactivity test, EM Observation - Moda exposure

Review of all the documents received from stake holder for dossier compilation , Query response and Life cycle management. Allocation of projects to regulatory associate & manage the team for all the regulatory submission activities

Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like – US, Canada, Europe, Australia

Exposure in investigation of UPD , OOS, OOT, EM and Change control & CAPA Management. Preferable for exposure in Regulator}’ and FDA Audits, Knowledge and exposure for aseptic operations and principal of its relevant equipment.

Regulatory Affairs professionals with 5 to 8 years of experience in regulatory strategy, dossier review, and submission for the US, EU, and Brazil markets.