Quality Assurance Customers Specialist

il y a 2 semaines


Brainel'Alleud, Belgique PolyPeptide Belgium Temps plein

**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.

**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.



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