Dqa Associate

6 months 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 non-commercial 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 Non-commercial campaign materials and issuance of CoA.
- Ensure phase-gate 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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