Expertise in Manufacturing process of Tabletting/Capsules/Injectabbles in-Identifying Relevant CPP,CCP &CQA
Leading the team as reviewr & expert in RCA & proposing relevent CAP
Must be able to train team members in QRM/IMPACT ASSESSMENT.
Must Aware of current expectation in regulatory requirements wrt CPV .
Must be having sound knowledge in evaluation of unit operations,Gap analysis.
Must be able to come out with Improvement plan on system & be able to understand system effectiveness