Hiring For Manager - Investigations QA

1. To follow up and review of investigations

• Coordinating for Gemba, data collection meetings and investigation plan meetings.
• To guide the documentation team and facilitate investigation process.
• Review of investigation report for completeness in line with identified root cause and CAPA.
• Ensuring circulation of MOM, action items at different steps of investigation process.
• Making sure that support or action response from relevant departments (Documentation, Engg, PRD lab, QC, PE, TAT & Production) in timely manner to complete the investigation.

2. Close monitoring of open investigations for timely completion.

3. Closure of quality events (Deviation, OOS, OOT & Complaints) in GMP Pro within due period, post investigation signoff.

4. Sharing of draft / approved investigation reports to client / product manager in line with quality agreement.

5. Review of investigation supporting documents including risk assessment reports, TNI, interview notes etc, but not limited to.

6. To follow up on interim actions and CAPA implementati