Sun Pharma

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

Evaluation and submission of application on online portal for getting domestic manufacturing and marketing permission from DCGI. Evaluation and submission of applications on online portal for import registration, import license of drugs and medical devices in India. 

This position would be supporting API Sales & Marketing projects for global API business. Preparation of monthly reports, internal and external data base, and annual expense budgets. Keep abreast with key regulatory changes and market developments in designated region, country.

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.