GMP Quality Assurance Specialist

Biopark; Louvain-la-Neuve; On-site; EUR 60,000 - 90,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Job description

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.