Our client, based in Central London, is a specialist Clinical Research Organisation providing clinical research services to pharmaceutical companies, clinical research organisations, academic institutions, healthcare sector and NGO’s. They are presently recruiting for a GCP QA Manager.
The Quality Assurance Manager heads the Quality Department and is supported by a QA Administrator. Specific duties and responsibilities of the role of the QA Manager include, but are not limited to:
Management of Quality Management System:
- Management, generation, reviews and facilitation of access to the controlled documents (e.g. SOPs, Policies).
- Maintenance of an independent audit schedule.
- Ensuring that audits are scheduled, planned, conducted, reported and followed up.
- Maintenance of CAPA system.
- Maintenance of Vendor Management System.
- Support Computerised System Validation and Implementation activities.
- Manage inspection readiness and inspection/audit hosting activities.
- Identify in-house GCP and/or QMS related training needs.
- Provide advice on GCP issues and non-compliance.
- Manage serious non-compliance investigations.
Lead communication across the organisation on GCP quality:
- Manage internal quality meetings.
- Provide broader compliance awareness and information.
- Foster a culture of quality and compliance awareness.
- Act as a member of the Senior Management Team to foster a culture of excellence and quality across the organisation.
- Previous proven experience in Quality Assurance and auditing in a GCP environment.
- Life Sciences degree or equivalent hands-on experience.
- Experience of authoring and developing SOPs and related documents.
- Excellent communication and organisational skills, and a flexible approach.
- Excellent knowledge of GCP & appropriate regional clinical trial regulations and guidelines.
- Experience in writing & developing SOPs & quality documents.
- GVP, GDP or GMP experience is also desirable but not mandatory.
Index Recruitment Ltd is acting as an Employment Agency in relation to this vacancy.
If you would like to apply please send your CV together with your salary requirements, notice period and reasons for leaving past and present employment.
"Due to the high volume of applications we currently receive, we are unable to respond to all candidates. If you do not hear from a Consultant within 5 working days unfortunately you have been unsuccessful on this occasion".