Maintain and Improve Laboratory systems
Provide routine and consistent checks to ensure data integrity, correctness, and completeness.
Conduct systematic, pre-scheduled audits which cover Quality Control and regulatory systems.
Tracking Corrective and Preventive actions, implementation and its effectiveness.
Gap analysis and recommendation/ solutions based on the Monthly reports reviews.
Review of Process packages during technology transfer.
Approval of major / critical change controls.
Feedback to Management on areas of actions required to enhance the compliance.
Preparation and updation of Corporate Quality Assurance guidelines.
Audit of API supplier for vendor qualification program...