Overall responsibility of Quality Assurance Department.
To ensure compliance with the statutory requirements a
Approval of Specifications, Master Formula Records, SOPs and Batch manufacturing records.
To ensure compliance of qualification & calibration of instruments / equipments.
To ensure validation of analytical methods, manufacturing /cleaning processes & utility systems.
To prepare training schedule and ensure training of personnel as per schedule.
Review and Approve Packaging material artwork.
To conduct vendor audits of raw / packaging materials vendors & contract laboratories.
To conduct or ensure self-inspection of the plant is carried out as per Schedule.
To co-ordinate with Stores, Production Department and Packing Department for quality improvements.
To ensure preparation, maintenance, distribution & control of MFRs, BMRs, BPRs, SOPs.
To review stability/ reports and validation documents and take appropriate actions.
To investigate Out-Of-Specification and review & approve deviations/change controls & CAPA.
Handling of Market complaints.
Responsible for product recall at site.
Up gradation of Site Master file, all other Quality system manuals & related documents.
Coordination with R & D for approval of vendors for raw & packaging materials.
To plan & conduct internal audit of different department as per schedule
To handle regulatory inspection & other country specific audits.
To ensure effective document control process and archival of GMP related documents.