Vacancy for M.Pharm as Senior Research Scientist at Apotex Research
Apotex Research Pvt. Ltd. is a wholly owned subsidiary of Apotex Inc. Canada which is a number one generic pharma co. in Canada. The position is for Bangalore location which has an R&D Centre, Manufacturing and a Bioequivalence Centre.
Post : Sr. Research Scientist
- Responsible for Technology Transfer of products from Formulation development to Commercial scale which includes performing Technical Risk Evaluation upon scale up/scale down of products prior to commercialization,
- Performing process optimization trials & Execution of Process Demonstration batches
- Providing support and Monitoring of Process Validation batches.
- Technology Transfer for Products from Outside to ARPL and Vice-versa.
- Review of Technology transfer package, manufacturing process comparison, performing feasibility and optimization trials, planning and generation of the manufacturing documents for execution of batches at ARPL.
- Product life cycle management (Alternate API source qualification by taking feasibility/optimization trials and submission batches & Product quality improvement).
- Work as a team and support our corporate values.
- To Perform Technical risk evaluation of the product and process.
- Evaluating the requirement of Demonstration batch and optimization batch for New Product Launch and site transfer products based on the regulatory requirements and technical risk evaluation.
- Preparation of Process Demonstration batch protocol and Report and circulate for review and approval, to recommend any modification in Formulation, equipment and in process after completion of Demonstration /optimization batch.
- To perform Technical investigations and reports if any for the closure of AQRS and Market complaints.
- To Monitor Process validations of New product launch, Site transfer products from internal (SVMP to LVMP) and External (from Apotex Inc to SVMP/LVMP) and Review process Validation protocols and Reports.
- To Review site transfer projects documents and execute the Feasibility trails, optimization trails and generate documents required for the execution of Submission, Demonstration or commercial batches as applicable.
- To take feasibility trails and optimization trails for Alternate vendor for API, and generate the documents required for the execution of Submission batches.
- Trouble shooting of issues raised during commercial batches execution.
- To perform the Equipment qualification activities and documents for the same as protocols and reports
- To generate and revise various documents like SOPs, Formats, Protocols, Reports, Master formulas, Packaging Order Masters etc.
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