Technology Transfer Engineer

2COMS Consulting Pvt. Ltd.
  • Visakhapatnam
  • 4-5 lakh
  • 1-5 years
  • Views
  • 07 Jul 2017

  • Production/ Manufacturing/ Engineering, Maintenance

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Support system for Formulation development team & Technology transfer team for development of commercially feasible & robust process.

o Participation in Process DOE & QbD documentation.

o Review of analytical data and further action plan related to process development.

o Review of documents such as finished product specification
(FPS), Data sheet, feasibility Guidelines, Authorized guidelines.

o Ensure successful execution and continual monitoring of technology transfer from R & D scale to Regulatory batch manufacturing and from Regulatory batch manufacturing to Commercial batch manufacturing.

o Response to process related queries (along with FD - Quality assurance dept) related to product development for all markets, such as US, EU etc.

o Training for any new dosage forms/ systems/ technologies introduced.

o Training to other Formulation development groups, as and when required.

o Involvement in technical discussion with suppliers/ customers.

o Process optimization and evaluation by applying statistical parameters such as CpK, sigma level, yield improvement and robustness of process.

o Implementation of Post approval changes.

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2COMS Consulting Pvt. Ltd.