CK Group are recruiting for a Senior PV Quality Specialist to join a pharmaceutical company at their site based in Welwyn, working remotely on a contract basis for 12 months. Role outside IR35.
Our client is a world leading innovative pharmaceutical company that is committed to improving the lives of patients.
The main purpose of the role will be to:
- Collect, analyse and report quality and compliance data to ensure adherence to internal/external standards
- Support PV/GCP Safety Inspections & Audits, providing support for Deviations and Corrective Actions/ Preventive, and support or lead aspects of procedural document management and other PV QMS activities.
- Lead the development of process documentation or groups of documentation, including process mapping and providing expertise to ensure processes are designed to meet quality objectives
Further responsibilities will include:
- Identifying data trends or process deficiencies, ensuring that deviations are appropriately reported and ensuring PV process improvements
- Production of the Pharmacovigilance System Master File PSMF for PV system compliance
- Supporting or leading preparation and conducting of internal process audits for PDS owned processes, specifically in the area of document request management
To succeed in this role, you will come from a Life Science background, with experience of data collection, management, reporting, or auditing
- Knowledge of CAPA processes required and experience of managing CAPA related activities desired.
- Good knowledge of key GVP regulatory requirements, in particular those relating to quality and quality management systems.
- Good understanding/experience in one or more specific area of GVP or Clinical Trial safety
Entitlement to work in the UK is essential. Please quote reference 50387.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Hendre Moolman
- Phone: 01438 743 047
- Reference: 50387
Website: CK Group
- Posted: 16th April 2021
- Expires: 14th May 2021