Dqa Associate

2 weeks ago


Hyderabad, Telangana, India Dr Reddy's Laboratories Limited Full time
Ensure quality compliance of products related to PD projects to meet all the requirements of Analytical development and Non-commercial GMP Manufacturing batches Testing activities in Product development and ASAT

  • Ensure quality compliance of Analytical method qualification, Technology Transfer & Validations of noncommercial products to meet the requirements of Regulatory expectations.
  • Management of Product Development /ASAT documents through data authentication, review, approval and archival.
  • Review for quality compliance of executed process and analytical records of development campaign.
  • Evaluation and closure of incidents/Change controls.
  • Release of development Noncommercial campaign materials and issuance of CoA.
  • Ensure phasegate compliance of development products entering/ interfacing the GMP and regulatory activities.
  • Ensure Product Life cycle management (LCM) of analytical methods by updating and tracking activities and documents to support regulatory interface.
  • Ensure proper handling, storage and reconciliation of critical reagents like RMPs, IRS etc.

Qualifications
Master in Science or M Pharm with 3-8 years experience into Development QA

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