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Job - CQV in India

India, India, India
Job type
Designer Jobs
Job Reference
Posted on
14 Sep 2016
View all Jobs from Energy_Jobline

About the Role:

  • 10yrs of Qualification, and Validation Experience in Bio-Pharmaceutical Industry
  • Ability to manage, lead, and mentor direct and indirect employees
  • Deep understanding of quality by design principles and ASTM 2500 requirements
  • Ability to develop, review, approves, and executes QV documentation and protocols (Risk assessments, IOQ, FAT/ SAT, etc.)
  • Prefer experience with API, Upstream and Downstream processes, Formulation/ Filling/ Inspection, Isolators, cleaning validation programs, and clean utilities
  • Deep knowledge of current FDA and EMEA regulations and demonstrated compliance to these requirements
  • Development of standards and guidelines for Qualification and Validation programs
  • Structure and plans execution of projects
  • Solves high complexity task independently
  • BE in Engineering or related technical degree

  • We are in search of employees who want to bring technical knowledge to life, who are strong in communication, have the ability to energize people.

  • As a successful QV Lead Engineer you are results-oriented and have a well-structured approach to your work.

  • By focusing on a smarter execution you work effectively, keep your promises and learn from your mistakes.

  • A global and passionate mindset is important as you will be working in a multi-cultural environment

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