Flen Health is an international family-owned company with ambitious growth plans in the pharmaceutical and medical device technological domain. Flen Health has a range of products for wound and skin care, several new products in the pipeline and research cooperation agreements in Europe and the USA. At Flen Health, we are convinced that we do help people live the life they love through developing innovative technologies and bringing these to patients across the globe. We focus on patients with topical inflammatory and infectious diseases.
We expect you to show grit, to take ownership of your initiatives, to go for it and we guarantee that you will then appreciate the results of your work, whether individually, as a team or company wide as Flen Health. As an intrapreneur, you will enjoy working in a multicultural diverse environment where trust and open communication are key, and where a positive can-do attitude drives sustainable growth. We offer a flexible working eco-system, enthusiastic colleagues, and an attractive remuneration package.
For our quality team, we are looking in BE for a Quality Project manager to implement the QMS software. This full time position for an immediate start will start as a contract for 12 months with the possibility to become permanent.
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
- Set up a new Quality Management System software that is compliant with the requirements of
ISO 13485, 21 CFR 820 and GMP.
- Develop the project plan together with the Software supplier and follow-up on project milestones and deliverables
- During testing and implementation of the different functionalities, identify and resolve problems and determine system improvements.
- Set up all processes accordingly in the new Quality Management Systems software, e.g. but not limited to: Document management, Complaint handling, CAPA handling, Risk Management, Change Management, Vigilance reporting, …
- Lead digital transfer of quality related documents.
- Setup the procedures, instructions, and trainings for implementation of the different QMS modules and provide training to key users.
- Upon go-live, you are the first point of contact to resolve problems and answer questions.
- Maintain proper communication with other departments to ensure good relationships in connection with matters related to the Quality Management System.
You will lead the implementation of a new GMP compliant Quality Management System software, in order to comply with 21 CFR 820, ISO 13485 and regulatory requirements for Medical devices to maintain the necessary quality certification.
Your qualifications & experience:
- Project management skills
- QMS Software implementation experience
- Analytical thinking & problem-solving capability
- A minimum of 5 years successful working experience in a quality department
- Knowledge/Experience of quality processes and procedures
- Knowledge of applicable GxP ; 21 CFR 820 and ISO 13485
- Fluency in English; both written and spoken
- Experience with Computer Systems Validation
- Master’s degree in Pharmaceutical Science or Master in Science or equivalent based on relevant experience
- Affinity with software development and validation
- 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: