Off-qa

1 week ago

Dahej, India Sun Pharmaceutical Industries Ltd Full time

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.

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