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GMP Quality Manager
2 months ago
Fresenius Kabi UK is seeking a highly skilled Quality Systems Specialist to join our team. As a Quality Systems Specialist, you will play a critical role in ensuring the quality and compliance of our products and services.
Key Responsibilities- Change Management and Deviation Management: Develop and implement robust change management and deviation management systems to meet regulatory requirements.
- Quality Investigations and Root Cause Analysis: Provide support to the site in completing quality investigations, conducting robust root cause analysis, and implementing relevant corrective and preventive actions (CAPA).
- Quality Assurance and Review: Ensure all quality management system (QMS) activities requiring quality assurance review/input are completed to a high standard within required timeframes.
- Quality Key Performance Indicators (KPIs): Develop and report on quality KPIs to identify trends and areas for improvement.
- GMP Training and Development: Identify, design, and deliver good manufacturing practice (GMP) training to staff to support improved application of GMP/GDP standards.
- Risk Management and Continuous Improvement: Implement appropriate risk management policies, procedures, systems, and processes, ensuring effective evaluation processes are applied across the site. Identify areas of continuous improvement in terms of quality culture, compliance, and site quality systems.
- Experience and Qualifications: Experienced QA professional with extensive GMP/QMS experience. Science/pharmacy-based degree (or equivalent). Strong communication and influencing skills.
- Technical Skills: Experience with change control, deviation, and investigation management, root cause analysis, and CAPA. Experience in the use of Trackwise. Experience in quality risk management. Robust understanding of sterile production.
- Competitive Benefits Package: Private healthcare, contributory pension scheme, role-specific tailored training and development plan, life insurance, 25 days holiday (rising to 27 after 5 years' service), and ability to buy/sell holidays.
- Supportive Work Environment: Maternity, paternity, and adoption leave, professional fees paid, bike-to-work scheme, long service awards, employee assistance programme, free onsite parking, and subsidised canteen.
- Commitment to Diversity and Inclusion: We are proud to foster a workplace free from discrimination. Diversity of experience, perspectives, and background create a better work environment and better products. Whatever your identity, we will give your application fair consideration.
