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Senior Research Associate-FD

4 - 6 years

6 - 8 Lacs

Posted:2 days ago| Platform: Naukri logo

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Job Type

Full Time

Job Description


  • Formulation development of NCE projects, generic projects and line extension projects
  • Preparation/review of literature summary and development report to the assigned product.
  • Involve in execution and/or supervision of formulation development, process development and manufacturing of GMP batches of assigned product.
  • Preparation/review of technical documents, which includes but not limited to MFC, BMR, BPR and Stability protocol following GDP.
  • Representation in departmental audit
  • Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same.
  • Execution and/or supervision of scale up/pilot scale batches in pilot plant under GMP condition.
  • Preparation and/or review of technology transfer documents and technology transfer to manufacturing site, whenever required.
  • Preparing/reviewing of QMS includes but not limited to change control, deviation, SOPs and OOS
  • Communication with cross-functional team and client via mails, meetings and oral communication
  • Provide training on but not limited to SOPs, technology, guidelines and project specific activities
  • Performing and/or supervision calibration and maintenance of R&D instruments and equipment
  • Procuring materials and machines change parts related to concern projects
  • Maintain safe and hygienic condition in respective department
  • Ensuring the use of personal protective equipment whenever required during batch execution
  • Attending training related to FD, EHS, QA or any other department (if applicable)
  • Ensure comply with EHS requirements while working in FD lab and Pilot plant.
  • Support to proposal preparation for upcoming new projects
  • Support to any additional responsibility/activity within or other department as and when required
Qualifications

Master of Pharmacy (Preferred Subject: Pharmaceutics)

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