5+

Responsible for Authoring and review of dossiers for submission to US, Canada, Europe, Australia, South Africa and other regulated markets. The Company focused on the emerging markets of Latin America, Caribbean, Francophone and Southern Africa and is today one of the leading suppliers of Pharmaceuticals in these regions, with over 2800 product licenses across the globe.

Review quality Dossiers in CTD format for new Generic drug submissions, in-line with the guidance and templates. Compile responses to deficiencies and deficiency management for the given portfolio of products.

Candidate should have knowledge of manufacturing operations of granulation, compression, coating and capsule filling, responsible to adherence cGMP guidelines. USFDA, MHRA exposure is must.

Must have handled critical equipment like reactor, centrifuge, blender, sifter, multi-mill, etc. Ensure that the products are manufactured as per the cGMP.

Graduate - Science or General B.Pharma, D.Pharma, MBA. Minimum 6 months experience in sales. Dr. Reddys Laboratories is an Indian multinational pharmaceutical company located in Hyderabad, Telangana, India.

Prepare and execute of Process validation, Hold time study protocol and compilation of Process validation reports. To monitor Equipment Qualification, HVAC and Utility validation schedule as per VMP.

Execution of analytical method optimization, development, validation, verification of analytical test methods related to Compendia, In-house developed methods, Site transfer methods, Regulatory queries, Method Life Cycle Management studies, Supplier Driven Changes and other procedural updations.Preparation of method validation/verification protocols and reports.

Proven track record of documentation review for accuracy and compliance to procedures essentially in analytical methods development, validation, transfer, stability studies, Design & Development.

Handling the lab instruments of HPLC, Dissolution, D.T , Apparatus, Weighting balance, Friability, Hardness Tester, FTIR, UV-Spectrophotometer.