Job Description:

1) QC/QA documentation

2) Develop and implement QC plans, strategies, and procedures for raw materials, in-process, and finished products.

3) Testing of Raw material/Finished Goods

4) Participation in the Audit

5)Lead and manage the Quality Control Department to ensure the highest standards of product quality

6) Oversee resource allocation, including personnel, equipment, and facilities, to optimize QC processes.

7) Coordinate and conduct training programs, ensuring proficiency and adherence to protocols.

8) Review and approve RM/PM/IP/FP/Stability/Water/Misc documents, SOPs, and specifications.

9) Provide guidance on method validation, ensuring alignment with industry standards.

10) Investigate and address deviations, OOS, OOT, incidents, CAPA, and change controls promptly.

11) Collaborate cross-functionally to integrate QC processes with organizational objectives.

12) Manage correspondence and interactions with regulatory agencies and internal stakeholders.

13) Ensure the QC team operates in compliance with cGMP, GLP, and other relevant quality standards.

14) Conduct regular reviews of QC processes, performance metrics, and initiate corrective actions when necessary.

15) Participate in cross-functional teams to address quality-related issues and implement improvements.