21 days ago
Title Quality Manager
DATS are looking for an experienced Quality Manager to join our client on a Contract basis. Our client is an international business that operates in several sectors in the UK . This role is for a contract Quality Manager to work for a period of 4 months from a client location in the Wirral.
We are looking for experienced candidates with facilities / manufacturing type experience in the area of pharmaceutical and medical industries.
The Quality Manager is the Facilities Management Representative with responsibility and authority for ensuring that the Quality related operations are maintained and undertaken to meet applicable GMP Regulatory Requirements. The role is responsible for ensuring compliance with all relevant regulatory requirements, responsible for the promotion of awareness of both regulatory and customer requirements throughout the Facilities Team, and that periodic GMP Quality Audits are conducted
- Be an active member of the Facilities Management team and ensure GMP Quality, Safety and Compliance related goals are established and implemented.
- Be accountable for driving a sustainable Quality improvement culture
- Manage the day-to-day Facilities Quality Operations and their interaction with other Customer departments within the Plant.
- Ensure the ongoing compliance with the Customer Quality Systems and local GMP requirements and represent Facilities in related interactions with external regulatory bodies, agencies and customers as and when required
- Implement processes & procedures to ensure continued improvement of Quality, Safety and Quality systems compliance
- Facilities Quality liaison with the Customer Quality Function
- Manage the training, development and coaching of members of the Facilities Operation to ensure ongoing GMP Compliance
- Participate in or manage Quality assessments of internal Facilities operations and third party subcontractors to analyse compliance and assess risk.
- Ensure systems are in place for effective Management Review.
- Ensure for the Facilities Quality operations that any required expertise is maintained to meet business needs.
- Ensure that processes needed to maintain the Facilities Quality Management System are established, understood, implemented, and maintained.
- Ensure an effective Facilities internal quality assessment and audit program is in place.
- Responsibility for Facilities related deviation investigations, root cause analysis and associated CAPA & effectiveness plans
- Responsible for Facilities related GMP change controls
- Required to have experience in operational experience in Quality, Engineering or a related discipline in a high-volume manufacturing environment with experience of Quality in a manufacturing environment producing pharmaceuticals or medical devices in compliance with EU GMP / FDA regulations.