Primary responsibilities include:
- Understanding GXP requirements such as (but not limited to) GCP, GVP, GMP, GDocP etc. and implementing/ monitoring them for QA function, as applicable.
- Facilitating the process of initiation of investigations and CAPAs, monitor progress and perform reviews/approvals including stakeholder management for closure of CAPAs.
- Ensuring that CAPA procedures and requirements are followed and met. Uphold standards for quality and compliance in pharmacovigilance.
- Performing QA functions pertaining to (but not limited to) Change management, CAPA, Deviation, Internal Audits, External Audits, Risk management, Innovation and Continual improvement.
- Escalating and involve stakeholders for resolution as needed, issues impacting the progress toward completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records.
- Reviewing evidence and approve closure of CAPA plans and effectiveness monitoring plans.
- Facilitating regular CAPA status and metric reports to ensure senior management awareness.
- Participating in governance/oversight activities including trend assessment or other quality review.
- Knowledge in the area of Clinical Operations is preferred.
Mandatory Skills:
- Quality Assurance
- Nonconformance management (CAPA, Deviations, Issues)
Preferred Skills:
- GCP
- Stakeholder management
- Conflict Resolution
- Problem Solving