Senior Consultant - Project Manager - Belgium, Switzerland
Biotech Quality Group (company)
Posted on : 30 March 2017
- Reporting to the top management, your mission is delivering customized quality systems solutions within customers’ operations.
- These project’s global contexts are: investments, facility revamping, manufacturing optimization, or technology/process transfer.
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.
- Lean Management
- Continuous Improvement of Production lines
- Quality Assurance operational improvement :
- Definition and execution of QA / qualification / validation (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 the management of expertise, resources, timing, results and reporting in order to ensure customers satisfaction.
- You also develop and upgrade internal processes and solutions for continuous improvement.
Desired skills and experience
- You possess a Master degree in Sciences, Industrial Pharmacy or Engineering.
- You have min. 10 years of experience in QA, validation, engineering, within GMP operational environments.
- You demonstrate a sound expertise in QA, QC, cGMP, GEP and complex projects management.
- You demonstrate customer, business and solutions orientation.
- You are fluent in French as well as in English. The command of Dutch is an asset.
- 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.
- Our company advises Biotechnology, Pharmaceuticals and MedTech european clients in their Quality Assurance strategy and daily organisation.
- Our company's founders have been involved over the last ten years in the Life Science industry, at various responsibilities in Quality Assurance, Regulatory Compliance, Engineering and Business excellence. They witnessed the paradigm shift, which is heavily impacting the industry since early 2000.
- Drop on drug prices, ever increasing pressure of regulatory bodies combined with the boom of generic products, have signed the end of the so-called « blockbuster » model.
- New models are emerging which have to rapidly mix new drug discovery – biotechnology being the engine for innovation – with the flexibility to reduce cost and shortening time-to-market.
- To face such a demanding challenge, Life science organizations, driven by both Management and Quality systems, are forced to adapt accordingly.