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SUN PHARMA Hiring for Executive at Vadodara, Gujarat, India

1 month ago

Vadodara, India SUN PHARMA Full time

To provide the value addition (technically) throughout the development process and to achieve successful on time filing.
  • 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 navigate the project technically and provide feasible technical solutions so as to develop a product recipe that can be successfully manufacture post approval.
  • To conduct Literature search and Patent search for assigned project.
  • To perform pre-formulation and formulation development trials with QbD approach and therefore to develop a robust formulation.
  • To manufacture batches for stability studies.
  • To manufacture batches for analytical method development and validation.
  • To troubleshoot commercial products and newer products to be scaled up.
  • To ensure successful scale up/exhibit batches at plant.
  • To prepare and review Test Request 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 Development Study Report after receipt of COAs.
  • To prepare Stability protocol and charge stability batches as per the protocol.
  • To prepare stability compilation sheet based on available COAs.
  • To fill form 29 for the grant of manufacturing license for the purpose of Examination, Testing and Analysis.
  • To prepare Technology Transfer documents like Sheet II, MPS, MF, Risk Assessment based upon CPP & CQA, FMEA and MSDS.
  • To prepare Common Pharmaceutical Document for DCGI submission.
  • To prepare Pre-IND/IND/NDA Package, Product Development Report based on studies performed and available COA for Regulatory submission.
  • To prepare Product Development Report along with relevant back-up data.
  • To prepare in process and finished product Specification.
  • To prepare 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 comply with the internal quality system while performing any activity.
  • To timely respond FDA query, if any. STANDARD OPERATING PROCEDURE TITLE: Organogram and Job Description preparation Document No. Version No. & Status Effective Date Review Due Date SOP023892 3.0 & Effective 10-Jan-2023 09-Jan-2026 Page 2 of 2
  • To co-ordinate with cross functional departments like ADD, RA, CQA, Plant for project / product related activity. “The above job responsibilities are not limited and the person shall fulfill additional responsibilities given by group leader / department head, if any.” Responsibilities assigned and approved by: _____________________________ (Group Leader / Section Head – Reporting Authority) Name, Sign and Date Responsibilities accepted by: I have read and understood the responsibilities mentioned above. Employee ___________________________ Name, Sign and Dat

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