Established in the early 90's, this organization has emerged as an integrated pharmaceutical company offering products to the global market. Headquartered at Delhi NCR, India and plant in North India, the Company develops, manufactures and markets a wide range of quality products in diverse area of treatment.Over the years, the organization has positioned itself as a significant player in the Russian and CIS markets and has expanded its foothold in the US, Europe, India and other markets. The key competitive advantage lies in having the Research & Development centre together with the world class manufacturing facility that has enabled it to provide end-to-end solutions from product development to marketing. The manufacturing facilities are approved by many regulatory bodies including EUGMP and WHOGMP thereby allowing the company to reach International markets.
Post : Research Scientist – Formulation Development
Job Description
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
Documentation:-
• 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
Additional Information:
Experience: 2-4 yrs in formulation of ophthalmic, injectable products for regulated market
Location: Gurgaon
Education: M.Pharm (Pharmaceutics) from reputed pharma institute
Industry Type: Pharma/Healthcare/Clinical research
Functional Area: F&D
End Date: 30th September, 2017
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