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 senior quality consultant for an immediate start. This temporary (6 months up to 1 year depending the project) 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
- Learning and development opportunities
- Competitive remuneration according to experience
You will lead the implementation of a new GMP compliant Quality Management System, in order to comply with 21 CFR 820 and applicable regulatory requirements to maintain the necessary quality certification.
- Set up a new Quality Management System according to GMP and 21 CFR 820 compliance.
- During implementation, identify and resolve problems and determine system improvements.
- Set up all processes accordingly in the new Quality Management Systems, e.g. but not limited to: Compliant handling, CAPA handling, Vigilance reporting, Risk Management, Change Management, Returned Goods…
- Lead digital transfer of quality related documents.
- Maintain proper communication with other departments to ensure good relationships in connection with matters related to the Quality Management System
Your qualifications and experience:
- A minimum of 5 years successful working experience in a quality department
- Fluency in English; both written and spoken
- Knowledge/Experience of quality procedures
- Knowledge of GxP
- Proficient in MS Office
- Knowledge of QMS
- 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
- 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: