Flen Health is an international, innovative, family-owned company based in Luxembourg, Belgium, the Netherlands, Germany and the UK.
Over the course of just a few years, Flen Health have gained the leading position in their home market, namely the Belgian wound care market and are working towards achieving this on an international level. Our company’s success is based on the dedication of our people and our safe and easy-to-use product portfolio which combines innovation with significant progress in wound care and is inspired by our motto. We help you to ‘live the life you love’.
We are looking for a quality specialist for an immediate start. This permanent full-time position will be home-office based.
What we offer:
- Excellent working conditions
- An innovative and inspiring work environment
- Independent project work & responsibilities within a professional team
- Career prospects
- Learning and development opportunities
- Competitive remuneration according to experience
You will support the operational performance of the quality department, ensuring the successful delivery of quality objectives, whilst adhering to regulatory compliance and achieving commercial success. You will set up and maintain the required quality management system, including internal and external audits, and will monitor its implementation in order to comply with 21 CFR 820 and applicable regulatory requirements to maintain the necessary quality certification. You will set up quality improvement programs to increase overall quality performance.
- Set up a new Quality Management System according to GMP.
- Set up and maintain the required Quality Management System, monitors implementation, identifies and resolves problems and determines system improvements.
- Handling of complaints and deviations (process or manufacturing related), including root cause analysis and subsequent CAPA handling.
- Prepare and complete quality documentation and reports regarding quality, and customer-requirements by collecting, analysing and summarising information and trends including failed processes, recalls, complaints and CAPAs.
- Participate in risk management, both product and business oriented.
- Participate in the Change control process.
- Digital filing of quality related documents in order to efficiently manage the Quality Management System.
- Registration and follow up of returned goods to guarantee and protect the safety of products.
- Administrative tasks related to temperature monitoring during transport, customer complaints and corrective/preventive actions (CAPAs).
- Assist in quality audits: audits from authorities and companies, internal audits, external audits with Flen Health customers and inspections. Perform
sexternal audits at suppliers/subcontractors.
- Promote quality awareness throughout the company. Train all staff concerning the Quality Management System and the use of Quality Management System.
- Encourage other departments to optimise processes and documents and help where possible.
- Assist in implementing quality strategies including global strategies that ensure procedures and policies meet applicable standards and regulations.
- Maintain proper communication with other departments to ensure good relationships in connection with matters related to the quality management system.
- Close cooperation with Regulatory department concerning submissions, design dossiers, technical files, clinical trials applications and other regulatory documents.
- Master’s degree in Pharmaceutical Science or Master in Science or equivalent based on relevant experience
- Excellent planning and organisational skills
- Strong communication skills both written and verbal
- Self-motivated team worker who is equally capable of lone working
- Strong interpersonal skills
- Problem solving ability
- Strong analytical ability
Are you interested in working with an ambitious and highly dedicated team?
Please send your CV and covering letter by using the form below: