DQA - Executive or Sr. Executive

5 days ago

Ahmedabad, Gujarat, India Chieron Active Ingredients Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Job Title: Sr. Executive/Executive Department: DQA

Job Summary, Duties/Responsibilities:

Ensure proper guidance on quality issues to the Product Development Teams

  • Review the documents received from R&D, AR&D, etc. so that the same can be shared with authorities and customers

. coordination communication and to respond customer complaint/query and regulatory authority.

  • Review the process change proposals and help the team members provide guidance on change proposals
  • Review the in-house expert reports/Quality overall summary (QOS) prepared by the team members
  • Ensure proper stage gate compliance at various stages of product development
  • Ensure that internal audits are conducted properly
  • Review the developmental reports and other documents
  • Ensure appropriate qualification of API.
  • Ensure appropriate qualification of external manufacturing sites
  • Ensure self-inspection programs are conducted properly across R &D.
  • Review the existing GMPs, STPs, GLPs or SOPs and update them if required
  • Help the team members manage change controls, deviations, incidents
  • Ensure international customers audits, regulatory audits, etc. is handled in a suitable manner
  • Ensure proper maintenance of central documentation, i.e. the Development Quality Assurance (DQA) document cell
  • Support audits/ quality investigations issues of other Business units
  • Ensure thorough Inspection of quality till the exhibit batch stage
  • Ensure quality by design, i.e. ensure robustness of product and process

Required Skills/Abilities:

Working experience in QbD and other new ICH, FDA guidelines

Education and Experience:

Required Education: M.Sc or equivalent.

  • Minimum Experience:

5-8years experience as DQA in research environment

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