Pharma Launch Validation Specialist (GMP)

Akkodis; Antwerpen; On-site; EUR 65,000 - 95,000; Full time

Job summary

Akkodis Belgium is seeking a Quality Validation Specialist to manage all validation aspects for new product launches in a GMP pharmaceutical environment. You will ensure processes meet regulatory requirements and maintain robust documentation.

You will collaborate with QA, production, R&D, and external partners to align validation activities with site objectives, coordinate risk assessments, and drive timely product launch milestones.

Qualifications

• Master's degree in a relevant scientific field.
• Excellent Dutch and good English written and spoken.
• At least 2 years of GMP experience in pharma/biotech.
• Experience with validation projects, protocols, and documentation.
• Strong communication, independent work style and attention to detail.
• Willingness to work early/late/weekends as needed.
• PhD considered an advantage for complex problems.
• Experience with aseptic formulation, filling, and inspection.

Responsibilities

• Validate and document processes for formulation, filling, inspection, shipping, and packaging per GMP.
• Execute and document urgent quality investigations with clear stakeholder communication.
• Draft validation and investigation protocols and coordinate sampling and testing.
• Perform risk analyses for new product introductions and define mitigations.
• Coordinate process and system changes for product introductions across functions.
• Manage project activities: planning, issue resolution, progress reporting, stakeholder updates.
• Collaborate with QA, lab, production, R&D, scheduling, and external partners.

Skills

Dutch language

English language

GMP experience

Validation projects

Project coordination

Strong communication

Technical writing

Education

Master's degree in Bioengineering/Pharmacy/Biochemistry/Biotechnology

PhD degree (advantage)

Job description

Akkodis Belgium is seeking a Quality Validation Specialist to manage all validation aspects for new product launches in a GMP pharmaceutical environment. You will ensure processes meet regulatory requirements and maintain robust documentation.

You will collaborate with QA, production, R&D, and external partners to align validation activities with site objectives, coordinate risk assessments, and drive timely product launch milestones.