Ensure compliance to good manufacturing practices.
SOP management – Review, approval, system compliance.
Training to the subordinates on cGMP requirements as per requirements of various regulatory agencies including documentation, system compliance, stability, analysis, in-process quality assurance, validations, etc.
Self Inspection – review, approval, system compliance.
Recalls – initiation, investigation, approval, system compliance.
In- process quality assurance – system establishment, review, compliance.
Documentation – Review, approval, system compliance.
Master documentation – review, approval, system compliance.
Process / equipment / cleaning / system Validation – review, approval, system compliance.
Calibration program – review, approval, system compliance.
Vendor Qualification – Audit, approval.
Deviation and change control management – Review, approval, system compliance.
Complaints – review, investigation, ensure compliance to the corrective and preventive measures.
Finished Product release – review, approval, system compliance.