Quality Operations Manager

il y a 2 semaines

Brainel'Alleud, Belgique PolyPeptide Belgium Temps plein

PolyPeptide Laboratories is a high-tech enterprise specializing in the development, manufacture and sale of **therapeutically active peptides**. PolyPeptide SA, Belgium, with approximately 320 employees is part of the international PolyPeptide Group with companies in Sweden, India, USA, France and Belgium.

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

**The key tasks are**:
To manage the Quality Operations & Cleaning activities at the Brain Site of PolyPeptide, covering the release of API, deviation, OOS, CAPA, change control, internal audit, annual product review, in order to meet the Quality Unit objectives, regulations and customer expectations.

**Organization**:

- Organize, manage and participate in activities of Quality Operations and Cleaning Team of PPL Braine site responsible for:

- Participating in on-line problem solving and conduct investigations together with Production, Engineering, Technical and QC departments
- Managing and approving change controls, CAPAs & deviations
- Assuring the release of API batches
- Being the point of contact for customers
- Managing customers audits and organizing the follow-up of findings
- Managing customer requests, complaints and recalls
- Reviewing and approving the documentation linked to quality agreements, process optimization & validation, analytical & QC activities, manufacturing & Cleaning operations, annual product review
- Checking compliance with quality systems, regulations and customer requirements
- Performing internal and external audits as required

**GMP and Quality**
- Develop, implement and manage documents related to Quality Operations activities in order to comply with the cGMP or other legislation, with PolyPeptide Quality System and customer requirements
- 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

**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.

**Planning**
- Plan and prioritize the activities of Quality Operations and Cleaning team in close relationship with the Production and Project management to minimize the production disturbance, meet the planning objectives as well as the Quality and Regulatory expectations.

**People management and team spirit**
- Ensure that the required and continuing training of the Quality Operations and Cleaning team is carried out and adapted according to needs
- Motivate, listen to and manage the personnel, maintaining a sound work spirit and discipline
- Implement “empowerment” and “full management” ways of life throughout the organization
- Manage relationship problems within the department
- Evaluate annually the direct reports
- As an employee and Manager at PolyPeptide you have the duty and responsibility to develop your own and your teams competences and skills of how and why to work efficiently and effectively.
- You are entitled to carry the human spirit and the fundamental values of PolyPeptide.
- You are required to actively participate and support the development of your team and cross-functional work, adapting to organizational and process changes.

**What we expect from you is**:

- **Master in Sciences **with minimum **5** years **experience in QA (GMP Environment and People management)
- Fluency in **French and English** is mandatory (spoken and written English)
- People manager and ability to work by project team
- 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.

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