Senior Executive - DQA

Key Roles & Responsibilities:
1. Oversee and support the overall activities during the product development life cycle from quality perspective in R&D (API and intermediates).
2. To understand the site needs with respect to system establishment and sustainability.
3. Author/ Review and approve the SOPs/work directions required for implementing the Quality systems in R&D activities as per GLP and regulatory requirements. Ensure effective implementation of SOPs/ work directions.
4. Review and approve Lab Familiarization Reports (LFR), Product development reports (PDR), Technology transfer, product specifications & STPs, analytical method validation, method transfer, qualification, calibration, process validation protocol and reports. Ensure effective execution of these activities.
5. Periodic audits of R&D laboratory. Ensure online documentation and review lab notebooks, PDR/LFR documents, analytical documents and stability data.
6. Effective maintenance of R&D records, distribution and archival systems.
7. Perform cGMP audit of R&D facilities and operations. Assist the team in auditing contract manufacturers/ vendors/ contract testing laboratory.
8. Ensure R&D team is trained for their relevant job function and GMP/ GLP training.
9. Provide quality related inputs to new projects, existing project, up gradations etc.
10. Participate in identification of key starting material (KSM)/ registered starting material (RSM) and ensure that it is correctly identified.
11. Participate in handling of OOS, OOT, Deviations, Batch failures, investigations and CAPA implementation at site.
12. Establish raw material standards by studying manufacturing/ R&D requirements-conferring with suppliers.
13. Responsible to follow the safety and environmental procedures deployed in the site.

Graduation and above in Science / Pharmacy