To plan & Coordinate the vendor Audits/periodic visits as per audit schedule.
To review and check the practices as per vendor questionnaires and Batch production records and analytical records during vendor audits.
To ensure the compliance of vendor qualification procedures.
To perform national & International vendor audits ,ensure audit compliance and closing of audit reports
Evaluate the vendor during qualification & re-qualification
To ensure the GMP & QMS documents compliance status of Contract manufacturing sites.
To provide and arrange GMP awareness program of Contract Manufacturing sites
To support Contract Manufacturing sites during 3rd party Audit
Ensure the implementation of CAPA and monitor the effectiveness of CAPA
To provide the support to closure of OOS, OOT, incidents, Market Complaints and CAPA
To review equipment qualification documents and FAT Inspection
To ensure the compliance level of qualification, analytical method validation, process validation, cleaning validation, stability study document at contract manufacturing sites.