Stability Engineer | QC SME | Remote After Onboarding

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

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.