Division

Department

Sub Department 1

Job Purpose

Assist, co-ordinate and get trained to develop and execute end to end formula and process development of products following good laboratory practices and continuously monitor its data and quality to have robust a product within the budget, timeline and regulatory standards

Key Accountabilities (1/6)

Collate pharma literature from USFDA etc. in order to utilize knowledge during product development

Perform literature search from USFDA and regulatory websites, pharmacopoeia etc.

Key Accountabilities (2/6)

Assist in providing and submitting all stage gates documents to CFT on the basis of data generated from development trials to execute batches at plant

• Assist in preparing all stage gates documents which include QbD documents (Stage I, II, III), SRM, FRM and ESM slides and development protocol for filling.
• Assist in designing product development strategy using hands on technical knowledge, literature search and risk assessment to have a plan of action with timelines

Key Accountabilities (3/6)

Assist in gathering data from pre-formulation studies by carrying out characterization of reference product and optimize the formula in order to develop a robust product

Assist in development of  the formula or process of an existing product by carrying out experiments, referring historical data and specifications and comparing with the reference product in order to improve quality or reduce the manufacturing time of the existing product

Key Accountabilities (4/6)

Support in providing indent through supply chain management to procure the Filters, RM and PM required during product development and submission batches

• Support in providing indent for raw material and packaging material
• Support in preparing manufacturing guideline, FPS, PDCL, PAF, Data sheet, RMCA code request, Test license requirements, mfg. licence communication, DCGI NOC request, TT report preparation and DP
• Support in compiling and assessing data generated during the development cycle through review and discussions to study the trend of the product performance and its quality

Key Accountabilities (5/6)

Key Accountabilities (6/6)

Major Challenges

• Delay in approval of documents due to multiple approval levels in cipdox

Overcome by: activity can be completed out of cipdox software

• Non availability of slots at unit leading to delay in timelines

Overcome by: slots availability can be ensured for proposed date of execution)

• Non feasible product identification leads to delay in timelines, product hold, involves huge cost and leads to revenue sharing with CMO
• Overcome by: Feasibility report for the execution of product at R&D and unit can be prepared which includes requirement of machine, capex etc.

Key Interactions (1/2)

• ADL department for analytical data (daily)
• Supply chain department for RM and PM (daily)
• QbD department for stage gates documents preparation (as per need basis)
• Jaagruti department for number of batches calculation/month (monthly)

Key Interactions (2/2)

Dimensions (1/2)

Development of 2projects in a year

Dimensions (2/2)

Key Decisions (1/2)

Recommendation for proper choice of RM, PM, Filters, instruments evaluated during product development

Key Decisions (2/2)

Education Qualification

Master in Pharmacy (Specialization in Pharmaceutics)

Relevant Work Experience

0-1 experience in R&D

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