Project initiation activities:-
- To perform literature search required for idea generation form (IGF) upon receiving IGF
- To review DMF received from suppliers
- To prepare product feasibility based on IGF received
- To create the item codes for material and procure material and Reference Listed Drug (RLD)
- To assist AD lab for Q1 Q2 estimation of RLD
- To draft tentative specification for API, RM and finished good
- To plan laboratory trials and stability batches
- To finalize proposed manufacturing process
- To initiate filter validation process with the filter supplier
- To prepare tech transfer documents including MFR, BOM, Process flowchart, Critical process parameters and critical quality activities
- To review product specifications, manufacturing documents
- To prepare documents for trial batches
- To prepare product development report
- To prepare and review SOPs and prepare response for internal audits
- To review documents related to filter validation
- Product Specification/ Tech Transfer/ Commercialization
- To organize and execute trial pre exhibit and exhibit batches at plant
- To execute first three commercial batches at plant
- To provide technical support for existing commercial batch
- To perform investigation of failures during exhibit batches/ stability (Out of Specification)
- Innovation
- As a stretch target come up with innovative and patentable formulations proposals or novel ideas which can reduce workload or expenses
Experience : 3 - 7 Years
Qualification : M.Pharm
Location : Gurgaon
Salary: INR 4,00,000 - 9,00,000 P.A
Industry Type : Pharma
Functional Area : R&D
End Date : 25th June, 2018
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