Specialist or Lead, Quality Assurance

Summary Role Details: Primary responsibilities include: Performing QA functions pertaining to (but not limited to) Change management, CAPA, Deviation, Internal Audits, External Audits, Risk management, Innovation and Continual improvement. 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. 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. Overall experience: 5 to 8 years in Life sciences domain Mandatory Skills: Quality Assurance Nonconformance management (CAPA, Deviations, Issues) Preferred Skills: GCP Stakeholder management Conflict Resolution Problem Solving Show more Show less