Engineer QC Stability | Brussels

Prothya Biosolutions (operating under Accord Plasma B.V. / Intas Pharmaceuticals); Brussel Hoofdstad; Hybride; EUR 55 000 - 90 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Group and health insurance

Meal vouchers

Eco-cheques

Flex Reward Plan

Holiday system

Résumé du poste

Prothya Biosolutions Belgium is seeking an Engineer focused on Stability within the Quality Control Support Global department. You will manage stability studies, plan protocols, follow QC testing, and generate reports while aligning with the Netherlands entity and driving improvements.

Requirements include a Master’s degree with 3+ years in a quality-driven field, knowledge of ICH/EudraLex GMP, and proficiency in English and Dutch and/or French.

Qualifications

• Master's degree in engineering/biotech/biochemistry with 3+ years in a quality-driven sector.
• Strong understanding of stability study design and regulatory requirements (ICH and EudraLex GMP).
• Knowledge of cGMP and regulatory requirements throughout stability testing.
• Ability to set priorities, stay flexible, and be organized.
• Good communication and teamwork; analytical, results-driven, problem-solving.
• Customer and service oriented; fluent English and Dutch and/or French.
• Proficiency with MS Office and other software packages.

Responsabilités

• Stability management: planning, protocol creation, QC testing follow-up, raw data follow-up and report creation, SOP management.
• Align with Prothya Biosolutions Netherlands on stability topics.
• Implement improvements related to Stability.
• Open records in the Quality Management System, investigate and plan follow-up.
• Communicate results and progress with other departments and different levels.
• Participate in other (improvement) projects; act as SME for Stability.
• Support other departments on various projects as SME for Stability.
• Participate as SME for Stability during client or regulatory audits.

Connaissances

Team player

Analytical

Problem solving

Customer oriented

Strong communication

Formation

Master's degree (Engineering / Biotechnology / Biochemistry)

Outils

MS Office

Description du poste

Report to a Global Supervisor of the Quality Control Support Global department.

Objectives:

In your role as Engineer, you will focus on Stability, 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:

• Stability studies of manufactured (intermediate) products

Main responsibilities and results:

In your daily activity, you report to the Global Supervisor of the Stability and QC Master Data team which is part of the Quality Control Support Global department.

Your main responsibility will be:

• Stability Management
  • Planning ;
  • Protocol creation;
  • QC testing follow up ;
  • Raw data follow up and report creation;
  • SOP management.
• Alignment with Prothya BiosolutionsNetherlandsfor the stability topic.
• Make improvements related to Stability
• Opening records in the Quality Management System (eg. Master Control), 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.
• Participate to other team (improvement) projects, therefore your critical eye and constructive feedback will be an asset.
• As SME for Stability, you will support other departments in various projects.
• Participate as SME for Stability during client or regulatory audits.

Profile:

• Education level: Master (Engineering, Biotechnology, Biochemistry, …) with at least 3 years of experience in a quality-driven sector (pharmacy, food, chemistry …).
• Strong understanding of stability study design, protocols, and regulatory requirements (ICH and EudraLex GMP guidelines)
• Ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulatory requirements throughout the stability testing process.
• You can set priorities and you are flexible and organizationally strong.
• You are communicative and enjoy working in a team.
• You are analytical, result-oriented, and problem-solving.
• You are customer and service oriented.
• You have a good knowledge of English and Dutch and / or French (both spoken and written).
• You have knowledge of the MS Office package and other software packages.

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.

• competitive salary
• group and health insurance
• meal vouchers
• eco-cheques
• Flex Reward Plan
• attractive holiday system exceeding the legal holidays
• 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!