Roles and Responsibilities:
1. Preparation of project plans for Analytical function
2. Review and approval of drug product specifications
3. To timely respond to regulatory queries as and when required
4. Coordination with cross-function teams namely formulation, quality assurance, packaging development, project management
5. Identify and audit external testing laboratories along with QA to ensure the external testing labs meets the expectation.
6. To coordinate with external testing laboratories, for the outsourcing analytical testing
7. To take part in an investigation related to product and analytical test methods.
8. Coordination with QC from manufacturing sites for analytical method transfer
9. To review and approve analytical protocols and reports
10. To ensure GLP and GMP practices are followed in the analytical laboratory
11. To ensure sufficient and required training is provided to the employees in analytical development.
12. To ensure all the required safety practices are followed during routine operations in the analytical laboratory.
No comments:
Post a Comment