QA Quality Engineer: GMP Operations & Compliance

Prothya Biosolutions (operating under Accord Plasma B.V. / Intas Pharmaceuticals); Neder-Over-Heembeek; On-site; EUR 65,000 - 85,000; Full time

Job summary

Prothya Biosolutions BE is seeking a Quality Engineer to ensure GMP-compliant operations and quality assurance across all levels. You will review batch records, manage deviations and CAPAs, and support risk analyses, qualification and validation projects.

The role requires a Master’s degree in a related field with at least 3 years in pharma/biotech, English fluency, and French or Dutch language skills. MS Office proficiency and knowledge of SAP/MasterControl are assets.

Qualifications

• Master’s degree in Chemistry/Industrial Pharmacy or related field.
• At least 3 years of experience in pharma, medical device or biotech.
• Knowledge of quality systems and GMP/SOPs is a plus.
• Proficient with MS Office; SAP/MasterControl is a plus.
• Fluency in English; French or Dutch is essential; knowledge of the other language is a plus.
• Analytical, problem solver, result-oriented, decisive.
• Pragmatic, customer-oriented, persuasive, communicative.
• Stress resistant, flexible, and willing to provide telephone support outside office hours.

Responsibilities

• Review batch records and prepare documentation for release.
• Assess events/deviations, OOS/OOL and complaints (to vendor).
• Monitor procedures, protocols and reports; correct and authorize them.
• Perform GxP checks on the shop floor and support improvements.
• Participate in risk analyses, qualification and validation projects.
• Contribute to training and informing employees about quality and regulations.
• Report to supervisor on batch record review and quality system records.

Skills

Quality assurance

Analytical thinking

Problem solving

Communication

Stress resistance

Flexibility

Education

Master’s degree in related field

Tools

SAP

MasterControl

Job description

Prothya Biosolutions BE is seeking a Quality Engineer to ensure GMP-compliant operations and quality assurance across all levels. You will review batch records, manage deviations and CAPAs, and support risk analyses, qualification and validation projects.

The role requires a Master’s degree in a related field with at least 3 years in pharma/biotech, English fluency, and French or Dutch language skills. MS Office proficiency and knowledge of SAP/MasterControl are assets.