Assistant Manager (Development QA) @ Galentic Pharma

Job Description

1. Responsible for supporting the Development Quality Assurance team, for the Research and Development activities at R&D level.
2. Review of Development documents and process for IND, NDA, and ANDA including Analytical Methods and PDR.
3. Implement the Development Quality System based on Quality by Design concept.
4. Develop, implement, track, review, approve elements of the Quality Management System including but not limited to SOPs, Change Control, Deviations, Incidents, CAPAs and Product Complaints.
5. Facilitate for performing Risk Assessment and monitoring of proposed mitigation plans.
6. Responsible for implementation of QbD tools wherever feasible in product development process.
7. Responsible for review of R&D lab notebook/lab trial review.
8. To verify the activities as being performed as per cGMP and GLP.
9. Responsible for preparation/review of exhibit batch MFR and MPR.
10. Responsible for review of stability study protocol at R&D level.
11. Co-ordinate between R&D and RA department for document filing.
12. Any other duties as per organizational requirements.

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