Executive - CMC QA

Role & responsibilities

1. Review of various formulation and packing development / technology transfer documents like but not limited to :

Master Formula, Master Formula Card, Product Development Report, Dissolution Development report, Elemental Impurity Risk Assessment Report, Stability plan, QbD based Risk Assessment report, Failure Mode Effect Analysis, Process Validation Protocol / report, Master packaging record, Study Protocol & report etc. as per internal guidance and procedures for various markets

2. To assist in developing procedures / system and for assuring compliance to them by the R&D function by identifying GAP and bridging through document review/audit

3. To work in coordination with Team members and CFT to resolve issues.

4. Evaluation of OOS/OOT data

5. Departmental Training Coordinator in Learning Management System as per defined role like assign job to a user, add / removal of user to a job, assign learning activity to a job, to create curriculum).

6. Function as EDMS coordinator

7. Prepare departmental internal report for management information

Educational Qualification : M. Pharmacy

Experience : 5 to 7 years