Senior Executive - DQA

Role & responsibilities

1. Ensure adherence to GxPs (GLP, GDP, GMP) through effective compliance management.
2. Maintain quality systems and procedures.
3. Implement and monitor quality metrics to ensure continuous improvement and compliance.
4. Plan and conduct internal audits to assess compliance with quality standards and regulatory requirements.
5. Conduct surprise lab visits to assess compliance with GxP.
6. Prepare for and participate in regulatory inspections of R&D facilities.
7. Coordinate client audits.
8. Conduct risk assessments and implement risk mitigation strategies.
9. Investigate and manage deviations, out-of-specification results, and non-conformances.
10. Develop and deliver training programs on quality standards, procedures, regulatory guidelines and requirements. Ensure training records are maintained and up-to-date.
11. Ensure the integrity and reliability of data generated at Molkem Labs.
12. Establish controls to prevent data manipulation and ensure compliance with data integrity principles.
13. Review QMS documents like change control, deviation, lab incidents, Corrective and Preventive Actions.
14. Monitor CAPA effectiveness and closure within defined timelines.
15. To review SOPs related to DQA and other cross functional team.
16. To review product specific documents e.g. Specifications, MOA, COA, Method Validation/Verification protocol-report, force degradation study documents, stability study documents, PDR, Scale up batch manufacturing documents, etc.
17. To review qualification documents (URS, DQ, IQ, OQ, PQ, FAT, SAT) as applicable.
18. To plan schedule for HVAC validation/qualification.
19. To evaluate requalification/revalidation requirements.
20. To review calibration and preventive maintenance schedules.
21. To involve in calibration and preventive maintenance activities based on requirements.
22. Collaborating with internal departments such as FD, ADL, Microbiology, Engineering, Regulatory Affairs, as well as external stakeholders & to ensure alignment on quality expectations.
23. Handling of inward and outwards of samples received for Public Testing Laboratory and reference products.

Preferred candidate profile

Male candidate having qualification B.Pharm/ M.Pharm, around 04 - 08 Years experience with Analytical Testing Laboratory (NABL accredited lab more preferable) and Formulation R&D.