Job Description

• To raise and get approval of UPD / PD / Change control and get approval from authorities.
• Handle LMS related activities and their timely completion.
• To do and arrange CFT meeting of related to QMS.
• To receive the market complaints and get closer timely after discussion with CFT team.
• To review and arrangement of all GMP format requirement like formats / log etc.
• Prepare yearly calibration schedule and their completion timely.
• To implement and monitor the CAPA.
• To complete the schedule training / on job training .
• To maintain / follow the cGMP / GQS guideline requirements..
• To handle change control, deviation and other GMP compliance related documents and ensure that all compliance related documents get closed within its time frame.
• Prepare all types of audit response like internal / external and any other regulatory authorities.
• Prepare and arrange new / schedule revision SOP and their archival.
• Archival and maintain of all formats.
• Maintain SOP index time to time of all packing related SOPs.

Skills Required