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Quality Operations Specialist

il y a 1 mois

Brainel'Alleud, Belgique PolyPeptide Belgium Temps plein

**F**or the Quality Assurance Department of our Belgian site located in Braine-l’Alleud, we currently have an opening for an experienced Quality Operations Specialist - NPI.**

**The key tasks are**:
Operations:

- Organize, manage and participate in QA activities from early-phase API manufacturing to Process Validation and in Cleaning activities, including:

- Review and approval of the documentation linked to quality agreements, process optimization & validation, analytical, operations and cleaning documentation to comply with the cGMP or other legislation, with PolyPeptide Quality System and customer requirements
- Management and approval of change controls, CAPAs & deviations and participation in on-line problem solving with other departments

Release of API batches:

- GMP and Quality
- Work with counterparts from Strasbourg and other sites to establish common (best) practices in quality related systems, policies and procedures
- Recommend changes in practices to enhance the conformance to GMP within all departments
- Perform internal and external audits as required
- Hygiene, Safety and Environment
- In collaboration with safety department, ensure proper training of personnel in place in order to prevent risk of accident or failure during operations.
- People management and team spirit

Experience in People Management
- Plan and prioritize the activities of the direct reports to minimize the production disturbance, meet the planning objectives as well as the Quality and Regulatory expectations.
- Ensure that the required and continuing training of the direct reports is carried out and adapted according to needs
- Motivate, listen to and manage the direct reports, maintaining a sound work spirit and manage relationship problems
- Implement "empowerment" and "full management" ways of life throughout the organization
- Evaluate annually the direct reports

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**:

- **Master in Sciences **with minimum **5 year experience in QA in a GMP **Environment & **NPI**
- 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.

**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.