Formulation Specialist Job in Mumbai at Cipla

Cipla is hiring for the role of Formulation Specialist!

Responsibilities of the Candidate:

• Collate and review Pharma literature from USFDA etc. in order to utilize knowledge during product development.
• Perform literature search from USFDA and regulatory websites, pharmacopoeia etc.
• Provide and submit all stage gates documents to CFT on the basis of data generated from development trials to execute batches at plant.
• Prepare all stage gates documents which include QbD documents (Stage I, II, III), SRM, FRM and ESM slides and development protocol for filing.
• Design product development strategy using hands on technical knowledge, literature search and risk assessment to have a plan of action with timelines.
• Gather data from pre-formulation studies by carrying out characterization of reference product and optimize the formula.
• Develop the formula or process of an existing product by carrying out experiments, reviewing historical data and specifications and comparing with the reference product.
• Provide indent through supply chain management to procure the Filters, RM and PM required during product development and submission batches.
• Prepare manufacturing guideline, FPS, PDCL, PAF, Data sheet, RMCA code request, Test license requirements, mfg. licence communication, DCGI NOC request, TT report preparation and DP.
• Compile and assess data generated during the development cycle to study the trend of the product performance and its quality.
• Prepare regulatory submission data by conducting R&D trials and executing regulatory submission batches at the unit.
• Conduct compatibility studies and generate data to propose MOC and vendors for filter, tubing, and manufacturing vessels.
• Conduct lab batches for Prototype process and formulae development.
• Prepare stability batches and generate stability data with finalized prototype formulation for submission to the regulatory agency.
• Provide deficiency response support by generating data at R&D/Unit required for approval of the product.
• Prepare AMG to implement changes required for the preparation of commercial BMR.
• Undertake deficiency response involved data generation at R&D for submission to regulatory agency.
• Submit batches for extra characterization, E&L study, force degradation study etc.

Requirements:

• Education Qualification: Master in Pharmacy (Specialization in Pharmaceutics)
• Relevant Work Experience: 1–2 year experience in R&D (Preferably in Injectab