Position: Engineer Improvement QC
Reports to the Supervisor Improvement QC
Objectives:
As an Engineer – QC Improvement, you are responsible for safeguarding the smooth running of the various processes within the department. Using Lean methodology, you will optimise the processes, together with the implementers, so that “flow” is guaranteed and the processes are “First Time Right” with a minimum of “waste”. If there are quality deviations in the lab that require more detailed investigation, you will be responsible for using problem-solving methodology to manage and report on this investigation. All of this must comply with the GMP quality system used at PROTHYA BIOSOLUTIONS BELGIUM. By doing this, you continuously improve the QC processes and do your part to ensure that the quality of the pharmaceutical products made by PROTHYA BIOSOLUTIONS BELGIUM meet the European and American c GMP guidelines.
Key responsibilities and result areas:
1) You are responsible for the safeguarding the processes within QC. You uncover and expose bottle necks, propose improvements together with the team, and then implement and follow up the result. This is done in compliance with the applicable regulations.
2) In the event of deviations, you support the lab staff in their investigations. If the investigations are complex because the root cause is not obvious, you take the lead in the investigation. You use problem-solving methodology and document your processes according to the quality guidelines in the quality monitoring system. To this end, you work closely with the quality department.
3) If the defined improvements resulting from the two points above require it and/or if Management requests it, you will:

• Create or adapt department-specific procedures and/or work instructions.
• Initiate change control as well as its implementation and follow-up.
• Initiate CAPAs (Corrective Action / Preventive Action) as well as their implementation and follow-up.
• Prepare and follow up on (monitoring) reports.
• Create periodic trending reports.
• Visualise processes (Andon).
• Investigate improvement proposals from employees, provide feedback and implement them, where appropriate.
• Participate in internal and external audits and inspections.

4) You are responsible for supporting PROTHYA BIOSOLUTIONS BELGIUM employees in the continuous improvement of our processes, in terms of both efficiency and quality.
Your profile:

• You have a Master’s degree or equivalent through experience (preferably in: Chemistry, Industrial Pharmacy or Biotechnology)
• You have at least 2 years of experience in a similar position in the pharmaceutical industry.
• Knowledge of quality systems is a requirement; experience with European and American GMP (Good Manufacturing Practices) guidelines and SOPs (Standard Operating Procedures) is necessary.
• You work efficiently with the MS Office package; knowledge of SAP/Master Control is a plus point.
• You have knowledge of and experience with Lean Management (e.g. Six Sigma, Value Stream Mapping, Andon, 5S, Gemba etc.).

• You can communicate fluently in English (both spoken and written), and you have a good knowledge of Dutch and/or French;

• You are analytical and good at solving problems.
• You are results-oriented and decisive.
• You are innovative and have experience in improving operational processes.
• You are customer-oriented, persuasive, communicative, and cooperative.
• You are a team player.
• You are stress-resistant.

Our Company
Prothya Biosolutions makes life-saving plasma medicines and is proud of that! Every day, Prothya colleagues take the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at a flexible and fast-growing company with an exciting history? At Prothya you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn!
We offer
Prothya Biosolutions Belgium 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 Belgium offers once a year.
We also offer an attractive holiday system exceeding the legal holidays and homeworking after a successful onboarding (after 3 months).
Furthermore, we value mutual respect and diversity is our strength.
At Prothya, you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn!


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