For the Quality Assurance Department of our Belgian site located in Braine-l’Alleud, we currently have an opening for an experienced Quality Operations Specialist - Development and Validation.
The primary goal of this function is to be the QA referent for Early Phase and Validation products and to perform activities of the QA Operation department.
The key tasks are (among others):
As a QA referent for products in clinical phases (GMP production) and validation, the major accountabilities include to:
- Be the quality point of contact for customers and participate in the project team meetings
- Manage customer requests, complaints, recalls and audits and organize the follow-up of findings
- Manage and approve change controls, CAPAs & deviations linked to the products and inform management in case of any major quality or regulatory issue
- Review and approve the documentation linked to the projects / products (MBR, analytical documentation, quality agreements, process validation, protocols and reports…)
As a member of the QA operation team, the function also includes:
- Write, review and approve documentation related to quality activities
- Be the QA operations referent for PPL projects in clinical phases (GMP production) and validation, provide quality support to other departments and support the continuous quality improvement
- Work within the Quality and Regulatory team to maintain focused, effective progression in line with department and PPL objectives
What we expect from you is:
- Master in Sciences with minimum 5 year experience in QA in a GMP Environment
- Experience in process validation
- Strong knowledge in GMP’s and ICH Q7 is a must
- Fluency in French and English is mandatory (spoken and written English)
- Excellent command of Word, Excel and PowerPoint
- High organizational skills, good interpersonal skills, flexibility in tasks and schedules
- Sense of responsibility, enthusiasm, diplomacy and team spirit
Why you should apply
At PolyPeptide, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients and customers. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, excellence and trust. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.
If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.
What we offer is :
- a full time contract
- an attractive salary
- extra-legal benefits and insurances
- a company car and fuel card
- a challenging position in an innovative and dynamic work environment with an open culture.