Quality Assurance Customers Specialist
Your responsibilities?
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 the internal 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
Your profile?
- Education in Sciences with minimum 3 years-experience in QA in a GMP Environment
- Experiment in customer complaints management
- Fluency in French and English is mandatory (spoken and written English)
- Excellent command of Microsoft office software’s
- High organizational and communication skills, good interpersonal skills, flexibility in tasks and schedules
- Sense of responsibility, enthusiasm, diplomacy and team spirit
Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
