Handling of CAPA activities

• Location CAPA tracking review and approval.

Unplanned deviation/OOS & OOT Investigation review and approval activity.

• Initiation, preparation, review, approval and closing of investigation

• Tracking, monitoring of recommended investigation action

• Open Investigation Tracking

• Trending of unplanned deviation on quarterly basis.

Preparation of Monthly/Quality metrics report

Handling of product quality compliant activities.

• Initiating the product quality complaint and risk assessment.
• To make investigation action plan and take approval.
• Preparation and closing of investigation.
• Tracking and monitoring of open product quality complaint
• Annual trend of product quality complaint

Handling of return goods and recall goods

• Review of return goods documents and to arrange sample for analysis (if applicable) and submit to QC.
• Take approval on recommendation of return goods, To assign CAPA to respective department.
• Tracking and monitoring of return goods material

Audit preparation and compliance activity

Preparation/revision of standard operating procedure

QMS data collection & presentation preparation

To provide QMS related data to corporate quality department

Other activity as defined in other SOP’s related to above job description.

Other activities instructed from time to time.