Halol

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

To monitor & prior checkup of equipment planned for usage in Scale up, Exhibit, Process validation batches i.e. Equipment preparation, vial washing and dehydrogenation, CIP, SIP System, PLCs, instruments etc.

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