Lead - Product Support (Product Development)

**Function**: Lead Product Support** Reports to a Supervisor of the Product Support department. **Objectives**: In your role as Lead, you will focus on continuous process verification (CPV) and you will participate in (improvement) projects. You can be a support in the other topics managed by the team You will join a multidisciplinary team that aims to manage and maintain at Prothya Biosolutions Belgium - The "Continuous Process Verification" (Trending) program - Support Operational activities during deviations - Product specification documents of manufactured (intermediate) products - Stability studies of manufactured (intermediate) products - Validation of the analytical methods used in QC laboratory **Main responsibilities and result areas**: In you daily activity, you report to Supervisor of the Method Validation, Stability and Trending team which is part of the Product Support department. Your main responsibility will be: - Being SME for the trending/CPV setup and SPOC for our site in Amsterdam regarding trending/CPV - Close cooperation with Production department - Understanding our data/processes and foresee impact of projects/changes on our processes - Compiling process data (Trend analyses of (Critical) Process parameters and (Critical) Quality attributes, summary reports,) - Converting data from different sources to Minitab - Analyzing/Interpreting of data, defining process stability and process capability - Preparation of periodic reports based on all data - Prepare and interpret comparative reports on the intermediate products - Opening records in het Quality Management System, make investigations and planning for a good follow up - Communicate the result and follow up of your activities with other departments and different hierarchical levels **Profile**: - Education level: Master (Engineering, Biotechnology, Biochemistry,...) with at least 5 years of experience in a quality-driven sector (pharmacy, food, chemistry...) - You have good knowledge of statistics and / or continuous process verification (trending), experience with Minitab is an asset - Knowledge of quality systems is a requirement, experience with European and American GMP guidelines (Good Manufacturing Practices) and SOPs (Standard Operating Procedures) is an asset - You can set priorities and you are flexible and organizationally strong - You are communicative and enjoy working in a team - You are result-oriented and problem-solving - You are customer and service oriented - You have knowledge of the MS Office package and other software packages - You have a good knowledge of English and Dutch and / or French and (both spoken and written) **Our Company** Prothya Biosolutions produces plasma preparations (including known products such as Cofact, Nanogam and Albuman). In addition, Prothya collects, tests and supplies blood plasma to purification and production sites worldwide. Prothya Biosolutions' mission is to provide healthcare organizations worldwide with high-quality plasma products. The company does this by creating value for partners and contributing to the health of people who depend on essential plasma proteins. Hence, Prothya's slogan: Creating Value, Sustaining Life. The company has various office and production locations in the Netherlands and Belgium and employs around 1,000 people. **We offer** Prothya Biosolutions BE is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training. In return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions BE offers once a year. We also offer an attractive holiday system exceeding the legal holidays. Furthermore, we value mutual respect and diversity is our strength. For each Prothya Biosolutions BE employee, from operators to the CEO, engagement means showing initiative. We expect all colleagues to contribute to achieving our annual objectives in order to take the organization towards it future challenges and successes. **Are you interested?** Send your CV and covering letter.