Position: Quality Control Environmental Monitoring Engineer | Brussels
Reports to the Manager QC
Objectives:
As a QC Environmental Monitoring Engineer, you are responsible to for the environmental and utility monitoring program (EM/UM). You are responsible for documentation and you act as an expert in the field of EM/UM. You follow up and implement changing regulations ensuring compliance with EM/UM pharmaceutical laws and regulations.
Key responsibilities and result areas:
1) EM/UM program:The EM/UM annual program and the associated planning is drawn up, coordinated and guaranteed in accordance with the applicable regulations.
2) you act as an SME and participates in multidisciplinary working groups and consultations within the EM/UM field
3) You guarantee quality and compliance. You will:

• Identify internal and external developments as well as, opportunities and bottlenecks and inform the manager on developments in the field of EU/UM;
• Create or adapt of 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.
• Train and provide presentations within and outside the own department about the field.
• Participate in internal and external audits and inspections.

Your profile:

• You have a Master’s degree or equivalent through experience (preferably in: Chemistry, Industrial Pharmacy or Biotechnology). Knowledge in Microbiology is a bonus.
• 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, experience with the European Pharmacopoeia is necessary.
• You work efficiently with the MS Office package; knowledge of SAP/Master Control/Minitab is a plus point.

• 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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