Quality Assurance Customers Specialist

For the Quality Assurance Department of our Belgian site located in Braine-l’Alleud, we currently have an opening for an experienced Quality Assurance Customers Specialist

T he key tasks are:

Operations:

• Organize, manage and participate in QA activities from early-phase to commercial manufacturing of customer specific APIs, including:
  • Review and approval of the documentation linked to quality agreements, process and analytical optimization & validation, manufacturing operations and stability to comply with the cGMP or other legislation, with PolyPeptide Quality System and customer requirements
  • Management and approval of change controls, CAPAs & deviations, OOS and participation in on-line problem solving with other departments
  • Writing of Process validation master documentation and Product Quality Review
  • Release of API batches in close collaboration with QA shopfloor team
• Work in a GMP and Quality environment
• Recommend changes in practices to enhance the conformance to GMP within all departments
• Perform internal and external audits as required
• In collaboration with safety department, ensure proper training of personnel in place in order to prevent risk of accident or failure during operations.

Information/Communication:

• Be the point of contact for customers quality topics (audits, customers requests, complaints and recalls)
• Inform management in case of any major quality or people management problem
• Make personnel aware of the importance of safety, environmental and GMP issues

What we expect from you is:

• Education in Sciences with minimum 5 years-experience in QA in a GMP Environment
• Experiment in process validation (is an asset)
• Fluency in French and English is mandatory (spoken and written English)
• Excellent command of Microsoft office softwares
• High organizational and communication 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

• a challenging position in an innovative and dynamic work environment with an open culture.