DQA Associate

Job Description

1. Data authentication, review, approval, archival, and retrieval of Product Development documents (e.g. Protocols, Reports Dossiers, etc.)
2. Review for quality compliance of executed process and analytical records of development campaigns.
3. Prepare and/or review SOPs, SDPs, FORMs, DRS, etc., as needed.
4. Evaluate the lab practices regularly as per defined standards.
5. Ensuring phase-gate compliance of development products entering/ interfacing the GMP and regulatory activities.
6. Assistance in Product Life Cycle Management (LCM) by updating and tracking activities and documents to support regulatory interface.
7. Track and update quality assurance metrics for the Product Development Organization.
8. Assist in releasing of development campaign materials and issuance of CoA.
9. Ensure proper handling, storage, and reconciliation of critical reagents like cell banks, RMPs, etc.
10. Ensure investigations are carried out in a structured way. Ensure timely evaluation of closure of incidents and change controls
11. Conduct audits and ensures proper closure of corrective and preventive action.
12. Liaise with DCQA for document control in PD (for issuance and retrieval).

Department: Biologics

Skills Required: Knowledge of Biologics product development

Location: Biologics Divison, Dr.Reddy's Laboratories Ltd, Bachupally, Hyderabad, Telangana, India

Education/Qualification: M Sc