Manager-1

6 days ago

Vadodara, India Sun Pharmaceutical Industries Ltd Full time

M.Pharm. (Pharmaceutics) with about 11 - 14 yrs experience in R&D product development with injectable product development that includes liquid, lyophilized and complex injectables.
- To have strong execution skills and to interact cross functionally and ensure timely submission and approval of the assigned projects as per agreed work plan.
- To provide the technical value addition throughout the development to achieve timely filing
- To conduct and review literature search and evaluate patent landscape for assigned project and work out the pathway for least time to effect successful submission.
- To perform pre-formulation and formulation development trials using QbD approach to develop a robust formulation.
- To manufacture batches for stability studies and analytical methods validation.
- To involve in scale up / exhibit batches execution at plant.
- To review Test Request reports for analysis of raw material (API / excipients) and Drug product.
- To write Laboratory Notebook to enter the details about drug product manufacturing operation.
- To prepare Development Study Protocol and execute the development study accordingly.
- To prepare and review Stability protocol to charge stability batches as per the protocol.
- To prepare and review Stability compilation sheet or development study report based on available COAs.
- To prepare and review Technology Transfer documents like Sheet II, MF, Risk Assessment based upon CPP & CQA, FMEA.
- To prepare Pre-IND /IND / NDA Package for regulatory communication.
- To prepare and set the in process and finished product Specification with scientific rationale.
- To prepare Product Development Report along with relevant back-up data for regulatory submission.
- To prepare and review SOPs related to laboratory equipment / instrument.
- To be a part of Equipment / Instrument Qualification activity in case of procurement of any new Equipment / Instrument and prepare and review qualification documents.
- To ensure compliance with the internal quality system while performing any activity.
- To timely respond FDA queries.
- To co-ordinate with cross functional departments like ADD, RA, CQA, Plant for project / product related activity.
- To be able to drive projects with internal and external stakeholders so as to meet the timelines.
- Provide novel solutions to simplify product development and develop robust products.
- To transfer projects successfully and troubleshooting if any with technical solutions so as to develop a product recipe that can be successfully manufactured post approval.

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