Location
Runcorn, Cheshire | United Kingdom
Job description
The Company
Fresenius Kabi is a global healthcare company that specialises in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used worldwide to help care for critically and chronically ill patients.
The Fresenius Group employs c.400,000 high-calibre professionals across the world, with a workforce of circa.1,000 professionals across the UK & Ireland.
The Role
Reporting to the Head of Quality, the successful candidate will be responsible for supporting the Head of Quality with the managerial and operational direction for the site QA department and will hold responsibility for maintaining and developing QMS for the site.
- Managing compliance of all departments to regulatory standards and guidelines by ensuring high quality standards and cGMP are maintained
- Providing managerial, coaching, guidance and leadership to the QA team, ensuring there is sufficient resource with adequate knowledge and experience, to maintain the operational area of product release and compliance with cGMP/ISO 9001 standards
- Coordinating all third party audits (e.g. MHRA inspection) and formulate any resultant action plans with realistic time lines
- Managing and controlling the Site Master File and the Quality Manual and the implementation of the resulting quality systems
- Managing the the company’s complaint and deviation handling systems
- Ensuring robust and effective complaint and deviation management systems are in place to meet customer and regulatory requirements
- Monitoring compliance with the Quality Management System, trend complaint and deviation data, generating trend analysis reports and ensuring effective corrective measures are implemented
- Working cross-functionally with other departments and third parties to reduce any non-conformances which may impact the Quality Management System, mitigating patient risk and ensuring compliance with regulatory standards, food standards and ISO 9001
- Conducting risk assessments and gap analysis of the current quality systems and formulate actions plans accordingly
- Approving all standard operating procedures for the aseptic production section and other closely related operational areas
- Identifying, designing and delivering GMP training to staff in order to support improved application of GMP/GDP standards
• Extensive Pharmaceutical background, preferably with a degree in Science or Pharmacy
• Experience in handling sterile dosage forms and Aseptic practices
• Proven experience in QMS elements and associated e-platforms preferably Trackwise and Documentum
• Experience in Internal and External Audit management
Job tags
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