The role
0301Contribute to the development of the audit strategy & program and plans related to the GVP area-PV processes, vendors, Partners and affiliates
02Act as a GVP Audit Program Owner when delegated by Global Quality GCP/GVP Head
03Perform and coordinate PV audits internally and externally and act whenever needed as delegated by Global Quality GCP/GVP Head
04Support and collaborate with GPV organization and the safety interfaces such as Medical Affairs, Regulatory Affairs and Affiliates, as applicable
05Ensure qualification of global and local ESP, as applicable in GVP regulated area per Sobi procedures
06Act as QA representative in PV Inspections and different initiatives or projects as needed
07Ensure GVP Audits management excellence of the end-to-end audit management process and overview of the assigned audits, as planned
08Assess and approve from quality perspective the PV deviations (global and local, as applicable), PV related CAPAs
09Prepare regular status report on performed audits, audit trending, PV deviation trending, PV CAPAs, trending and agreed upon metrics to ensure Quality oversight
10Ensure the updates needed for audit related information to the PSMF and participate actively to the QPPV extended meeting
11Contribute to the GVP audit strategy according to SOPs
12Prepare GVP Audit annual plans according to SOPs, ensuring the risk assessment and prioritization of the GVP Audits are performed in collaboration with GPV organization and with GVP Audit program owner
13Authoring GVP QA related processes, review and approve the PV related SOPs (or SOPs from other RDMA and Quality areas with implicit or interfaced PV activities eg Medical information, regulatory, medical affairs, compassionate use)
14Ensure active contribution in the cross functional team with procurement and business owners for GVP requirements and documented QA qualification of GVP service providers and review PV provision in contracts/Quality agreements, as applicable
15QA representative during PV inspections and partner audits and promote the Inspection Readiness framework and continuously quality mindset across Sobi
