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Quality Assurance Specialist
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: Design and deliver Good Manufacturing Practice (GMP) training to staff to support improved application of GMP/GDP standards.
- Risk Management and Compliance: Implement appropriate risk management policies, procedures, systems, and processes to ensure effective evaluation and compliance across the site.
- Continuous Improvement: Identify areas for 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, and experience with change control, deviation, and investigation management, root cause analysis, and CAPA.
- Technical Skills: Experience in the use of Trackwise and quality risk management.
- Understanding of Sterile Production: Robust understanding of sterile production.
- Private Healthcare: Comprehensive private healthcare plan.
- Contributory Pension Scheme: Contributory pension scheme with employer contributions.
- Role-Specific Training and Development: Tailored training and development plan to support your career growth.
- Life Insurance: Four times annual salary death-in-service benefit.
- Holidays and Leave: 25 days annual leave (rising to 27 days after five years' service) and ability to buy/sell holidays.
- Maternity, Paternity, and Adoption Leave: Comprehensive leave policies for new parents.
- Professional Fees: Professional fees paid.
- Bike to Work Scheme: Cycle-to-work scheme.
- Long Service Awards: Recognition of long service milestones.
- Employee Assistance Programme: Access to employee assistance programme.
- Free Onsite Parking and Subsidised Canteen: Convenient parking and subsidised canteen facilities.
- Blue Light Card: Discounted shopping and leisure activities.
- Charity Fundraising and Volunteer Days: Opportunities to support charitable causes.
- Company Funded Family Days Out: Regular family days out.
