(Biologics DQA)

Roles & Responsibilites:

1. Establish, implement, and continuously improve quality systems.
2. Review and approve method development reports.
3. Review and approve method qualification reports.
4. Review and approve method transfer protocols and reports.
5. Review and approve specifications and methods of analysis (MOAs).
6. Review and approve clone selection and development reports.
7. Review audit trails for all applicable equipment and instruments.
8. Issue, retrieve, and control development-laboratory documents, including batch records, logbooks, protocols, quality/technical agreements, and layouts.
9. Review and approve RCB establishment reports.
10. Review and approve characterization reports.
11. Verify the receipt of clones and cell banks, including supporting documents, certificates, transit data-logger reports, and applicable test and characterization reports.
12. Review experimental data recorded in the electronic laboratory notebook (eLN) for analytical, bioanalytical, process development, and cell-line development activities.
13. Review and approve upstream, downstream, and formulation process-development reports.
14. Review and approve consistency-batch summaries.
15. Review and approve point-of-use (POU) study protocols and reports.
16. Review and approve technology-transfer reports.
17.



Participate in client project meetings and provide quality support to internal and external stakeholders.
18. Manage quality management system (QMS) activities for development operations, including change controls, incidents, customer complaints, corrective and preventive actions (CAPA), and quality risk assessments.
19. Provide quality oversight for development project activities performed at external manufacturing sites.
20. Conduct routine development-laboratory rounds to verify that facilities and operations remain in a compliant state.
21. Review raw-material and packaging-material specifications and support material categorization for vendor qualification.
22. Handling of vendor qualification.
23. Review and approval of equipment / instrument qualification documents.

Qualification & Experience

- Qualification: M.Sc./M.Tech in Biotechnology, Biochemistry or related disciplines.
- Experience: 8-12 years of relevant experience in Development Quality Assurance (DQA), Biologics Quality Assurance, Quality Systems, or related quality functions within the biopharmaceutical industry.
- Prior experience in biologics development, analytical development, process development, technology transfer, QMS management, and vendor qualification will be preferred.

📌 Specialist - DQA (Hyderabad)
🏢 Aurigene Pharmaceutical Services
📍 Hyderabad