Science Solutions - QA & Compliance Manager - Pharmaceutical & Medical Devices
Up to £50k + bonuses
This site is due to become the centre of excellence for a global operation.
We need QA/Compliance/Quality Managers with a background in NON-Production based ISO 13485 Regulations
Essentially you will be the subject matter expert for Medical Device registrations
Full Job details ...
- To support the Head of Quality in the development implementation, maintenance and continuous improvement of the QMS.
- To ensure that compliance with the company's Specials Manufacturing Licence and Wholesale Distribution Authorisation are maintained and that all applicable company operations and processes conform to the principles of GMP and GDP.
- To manage and develop the Quality Assurance and Compliance team direct reports.
- To build strong cross-functional working relationships with manufacturing staff and other departments within the business to engender a Quality Culture.
- Compliance of the site to regulatory standards and ISO9001:2008 & ISO 13485 by ensuring high quality standards and GMP are maintained.
- Provide leadership, coaching and guidance to the Quality Assurance and Compliance team to ensure compliance, high quality standards and GMP are maintained.
- Support the Quality Assurance and Compliance team in developing, implementing, maintaining and continuously improving the Quality Management System.
- Conduct risk assessments and gap analysis of the current quality systems and formulate actions plans accordingly to continuously improve the Quality Management system.
- Monitor compliance with the Quality Management System, trend data and implement effective corrective measures as required.
- Manage non-conformance issues and formulate edicts on the standards that need to be applied to maintain compliance with regulatory expectations.
- Support Complaint investigation and closure review to maintain compliance with regulatory expectations.
- Provide Validation support across the business, in line with regulatory requirements.
- Support the Change Management system to maintain a 'State of Control' across the business.
- Perform and monitor audits both internally and at a partner or supplier operations to support the identification, action and close out of non-compliance issues and to identify areas for continuous improvement.
- Deputise for the Head of Quality for the review and approval of defined Quality documentation.
- To identify, design and deliver GMP training to staff in order to support improved application of GMP standards.
- Maintain an overall knowledge of the current status of compliance across site with rules and standards and maintain an awareness of developments in the field of Medical Devices & GMP to ensure a continued provision of an up to date service
- Control of Quality Assurance and Compliance cost centre including personnel expenses
- Direction and control of the Quality Assurance and Compliance team.
- For the management of key quality system and compliance activities to ensure that regulatory, internal and customer quality standards are met
PLEASE APPLY TO BE REVIEWED IMMEDIATELY
- Quality System
- Medicinal license