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Opening for R&D - FDD Documentation at J. B. Chemicals & Pharmaceuticals

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Clinical research courses

J. B. Chemicals & Pharmaceuticals Ltd. (JBCPL), known to many as Unique Pharmaceutical Laboratories is one of India's leading global pharmaceutical companies. The company manufactures and markets a wide range of pharmaceutical formulations.

Post : Executive - R&D Formulation

Job Description:

  • Patent landscaping by coordination with IP team.
  • Planning and Procurement of RLD samples, Excipient, Packaging materials, Equipment, Change parts, Spare parts etc., for both development and scale up batches.
  • Execution and evaluation of Preformulation, feasibility, formulation development, formula optimization and process optimization trials.
  • Monitoring stability study of development and scale up batches and reviewing data.
  • BE study design and protocol review as per requirement of clinical team.
  • Documentation and Review of development and technology transfer related documents includes MF/MFC/PDR/Lab note book/Stability protocols.
  • Review of Specification of Drug substance, Drug Product, Excipient and Packaging Materials.
  • Planning for procurement
  • Owing responsibilities in planning and smooth execution of scale up and exhibit batches at manufacturing locations by applying risk assessment and risk mitigation strategies.
  • Coordination with regulatory for dossier filing.
  • Responding to deficiency query of products under review by regulatory authorities.
  • Timely updates of project status to superiors and highlighting milestones and constraints of projects.

 

Additional Information:
Experience: 2-5 years
Location:
Mumbai
Education: B.Pharm, M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area:
R&D FDD Documentation
End Date: 16th June, 2017

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