Quality Assurance Officer - GMP Operations

Biopark; Louvain-la-Neuve; In loco; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

Inteliphage in Belgium seeks a Quality Assurance Officer to ensure GMP compliance across R&D to production. You will report to the Head of Quality and collaborate with Production, QC and Engineering to uphold quality standards and regulatory readiness.

You bring 3+ years in GMP QA, hands-on equipment qualification experience, and proficiency in EU GMP guidelines. The role is on-site, language skills in French and English are required, and a valid work permit for Belgium is essential.

Competenze

• Bachelor's degree in sciences or related field.
• 3+ years of Quality Assurance experience in a GMP-regulated environment.
• Good knowledge of EU GMP (EudraLex) and its annexes, especially Annex 1 and Annex 15.
• Hands-on experience with equipment qualification and validation documents (URS, IQ/OQ/PQ).
• Structured, detail-oriented and pragmatic with practical compliant solutions.
• Strong communication skills; able to work with production and regulatory teams.
• Fluent in French and capable of using English for procedures.

Mansioni

• Act as the QA point of contact for production teams and provide day-to-day support on the floor.
• Carry out GMP walk-throughs, support internal audits and regulatory inspections.
• Promote a strong quality culture and train staff on GMP principles and procedures.
• Review batch records and production documentation; manage deviations, CAPAs and change controls.
• Participate in equipment qualification, qualification document reviews and change control activities.
• Help set up GMP-compliant production processes and assist in documenting SOPs and QMS improvements.

Descrizione del lavoro

Quality Assurance Officer - GMP Operations Inteliphage

In a regulated GMP/GxP environment, quality is at the heart of every process, every decision, and every product delivered.As a Quality Assurance Specialist, you play a key role in ensuring compliance across the full product lifecycle, from R&D to production. You help maintain the highest quality standards, secure operations, and strengthen trust with regulatory authorities, partners, and ultimately, patients.

As a Quality Assurance Officerat Inteliphage, you will report to the Head of Quality, you will make sure our equipment, processes and production activities comply with GMP requirements. You will work closely with our Production, QC and Engineering teams, both on project implementation and day-to-day operations.

What your days could look like

QA Operations

• Act as the QA point of contact for production teams and provide day-to-day support on the floor
• Carry out GMP walk-throughs and support internal audits and regulatory inspections
• Promote a strong quality culture and train staff on GMP principles and procedures
• Review executed batch records and production documentation
• Manage and assess deviations, CAPAs and changeManage and assess deviations, CAPAs and change controls

Equipment Qualification

• Take part in the qualification of equipment, utilities and facilities, following a risk-based approach
• Review and approve qualification documents: User Requirement Specifications (URS), Validation Plans (VP), and IQ/OQ/PQ protocols and reports
• Assess deviations and non-conformities that arise during qualification, and follow up on corrective actions
• Help maintain the qualified status of equipment (periodic reviews, change control, requalification)

Production Processes and Procedures

• Help set up and roll out GMP-compliant production processes
• Write, review and approve SOPs, work instructions, forms and batch records
• Help build and continuously improve the Quality Management System (QMS)

What you bring to the table

You ideally bring:

• At least a Bachelor's degree in sciences (biology, biotechnology, chemistry, pharmacy, bioengineering or similar)
• +3 years of experience in Quality Assurance in a GMP-regulated environment (pharma, biotech, ATMP or similar)
• Good knowledge of EU GMP (EudraLex Volume 4) and its annexes, especially Annex 1 and Annex 15
• Hands-on experience with equipment qualification and validation documents (URS, IQ/OQ/PQ)
• Structured, detail-oriented and pragmatic, with the ability to find compliant solutions that work in practice
• Good communication skills and comfortable working in the field alongside operational teams
• Fluent in French and ability to use English for understanding and writing procedures
• MUST have a valid work permit for Belgium.
• Work to be performed mainly on site

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