CK Group are recruiting for a Pharmacovigilance Quality Director to join a world leading pharmaceutical company who are based in Hertfordshire on a 12-month contract basis (inside IR35).
This company is one of the world\'s largest biotech companies and is a leading provider of cancer treatments and in vitro diagnostics.
The main purpose of the role will be to
- Provide supporting activities related to the conduct of PV/GCP Safety audits and inspections and leading other aspects of PV system related QMS activities.
- Lead activities related to the end-to-end management of process deficiencies and non-compliances
- Accountable for key Quality Responsible role activities including assessment and categorisation of deviations for criticality, identification and management of a Core Team to support management of the CAPA, leading Root Cause Analysis activities, drafting CAPA plan and effectiveness measures, overseeing CAPA plan implementation and performing effectiveness changes, identification and escalation of issues if timelines may be at risk.
Further responsibilities will include:
- Leading in the design, development, maintenance & support of one or more core Quality Management processes, required to deliver effective compliance for the PV system
- Serving as the principal subject matter expert (SME) for the assigned area(s) of process, working in close partnership with Business Process Owners
- Assisting and participating in PV Inspection Readiness activities
To succeed in this role, you will come from a Life Science background and considerable experience in pharmacovigilance or clinical safety related area, with expertise in quality related activities.
- The capability to utilize various quality management/analysis and/or project management methodologies
- Experience of data collection, management, reporting, or auditing is desired
- Strong experience in design and management of CAPA is required.
- Strong knowledge of key GVP regulatory requirements, in particular those relating to quality and quality management systems.
For more information or to apply for this position, please contact Hendre Moolman on 01438 842 970 or email email@example.com quoting job ref 51753.
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- Agency: CK Group
- Contact: Hendre Moolman
- Phone: 01438 743 047
- Reference: 51753
Website: CK Group
- Posted: 27th September 2021
- Expires: 25th October 2021