Quality Assurance
4 days ago
- Updating the trackers and tracking of CAPA & Deviation.
- Review of CAPA projects, action implementation plan and effectiveness monitoring plan.
- Review evidences and perform closure for CAPA and CAPAEM records.
- Data preparation for Review Board Meeting, Management Review Meeting and other meetings as required.
- Prepare trending report for CAPA, EVENT.
- Facilitate CAPA Review Board Meeting.
- Preparation and review of Quality Assurance Standard Operating Procedure.
- Participate in external or internal audit, and coordinate external audit responses and compilation of supporting documents for the evidence binder.
- Preparation and review of study protocols related to Quality Assurance department.
- Impart training on Quality Assurance procedures.
- Ensure closure of all QMS elements related.
- Review justification for delay (if any) in CAPA closure.
- Ensure CAPA is appropriate as per root cause.
- Verify the CAPA implementation and effectiveness for closeout.
- Review and approval of CAPA plan and timelines.
- Track CAPA and CAPA effectiveness check plan with stakeholders to complete CAPA actions on time.
- Define CAPA effectiveness check plan in track-wise and assign to applicable stakeholders.
- Archive original records.
- Initiate any QMS element related.
- Review investigation report, impact assessment and closure of deviation report.
- Coordinate Investigation Review Board Meeting.
- Coordinate and summarize the plant shutdown activity.
- Review of event, incident and deviation.
- Support other QMS activities depending upon the requirement.
- Any other task given by reporting manager from time to time.
- Assess the event and issue escalation notification to management and communicate to customer/partner as necessary.
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