Our customer is a European innovative consulting company specialised in the Bio-pharma and Biotech sector. They deliver customised solutions in operational quality systems development and optimisation.
Our customer is leader on its market: renowned as an innovative, professional and results oriented company. They trust and can count on their 30+ team members’ sound experience, drive and high-end expertise.
Our customer brings added value and implements effective solutions to Bio-pharma and Biotech companies. Their single way of working enhances them to deal with challenging but really interesting projects.
As part of its expansion in Belgium and abroad, our customer is actively looking for a :
Quality Systems Senior Consultant
Mission :
Reporting to the top management, your mission is delivering customised quality systems continuous improvement solutions within customers’ operations. These project’s global contexts are: investments, facility revamping, manufacturing infrastructure optimisation, or technology/process transfer.
Responsibilities :
Your main responsibilities are Managing, together with a team :
- Project and continuous improvement of manufacturing processes (cGMP) :
- Design Studies review ;
- Risk analysis of investment projects/revamping ;
- Commissioning and qualification of installations ;
- Coordination of the overall planning ;
- Management of pharmaceutical engineering projects.
- Quality Systems continuous improvement :
- Quality systems diagnostic ;
- Project management and change management ;
- Workshop organization (value stream mapping, change management).
- Quality Assurance operational improvement :
- Definition and execution of validation & qualification strategy (including ICHQ8/Q9/Q10, FDA guidance);
- Remediation projects for operational non-compliance (change control, CAPA & complaints)
- Preparation of inspections, operational support during health authorities inspections.
In all these projects, you are responsible for expertise, resources, timing, results and reporting in order to ensure customers satisfaction.
You also develop and upgrade internal processes and solutions for continuous improvement.
Profile :
- You possess a Master degree in Sciences, Industrial Pharmacy or Engineering.
- You have min. 10 years of experiences in QA, validation, engineering, revamping, and/or continuous improvement within operations in the Bio-pharma /Biotech industry.
- You demonstrate a sound expertise in Quality Assurance and Control, cGMP, GEP.
- You are comfortable with complex projects management.
- You demonstrate customer, business and solutions orientation.
- You are ready to work in Belgium, and occasionally in France and in Switzerland.
- You are fluent in French as well as in English. The command of Dutch is an asset.
Offer :
- A challenging position within an innovative consulting company.
- A dynamic work environment with an open and professional culture.
- Varied interesting projects and contacts within Bio-Pharma/Biotech industries.
- Learning and evolution opportunities on an international scale.
An attractive salary package coherent with your experience, performance and skills.