Sun Pharma

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

Responsible for QMS Team lead for Block, Exposure to US, EU and CA regulatory requirements, Handling of market complaint

EM, Media 111 visual inspection , Aseptic area monitoring, Water and Bioburden testing & Sterility testing & BET Testiug , IQ, OQ, PQ of equipment, Biological reactivity test - Moda exposure

To assist establishing a system in accordance with Good Manufacturing practice guidelines and responsible for follow established , new procedures, new procedures, maintaining and updating existing procedures in the department.

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

Review of various formulation and packing development, technology transfer documents like but not limited to Master Formula, Master Formula Card, Product Development Report, Dissolution Development report, Elemental Impurity Risk Assessment Report, Stability plan, QbD based Risk Assessment report, Failure Mode Effect Analysis, Process Validation Protocol