Job description
Key Responsibilities
1. Validation Strategy & Documentation
Ensure a comprehensive and compliant validation lifecycle, including:
* Development, review, and approval of validation documentation:
o Validation Plan (VP)
o IOQ/PQ validation protocols (equipment and process)
o IOQ/PQ validation reports (equipment and process)
o Verification protocols
o Verification reports (when applicable)
o Risk assessments
o Technical reports
o Validation Summary Reports (VSR)
* Guarantee alignment with regulatory expectations and GMP standards.
* Ensure a “state-of-the-art” validation strategy from planning to final reporting.
2. Validation Execution & Coordination
* Coordinate validation activities within the project scope.
* Lead and/or participate in validation-related meetings.
* Ensure timely execution of validation protocols.
* Act as the central point of contact between TRD, GMP, Drug Substance, and Drug Product stakeholders.
* Monitor progress and escalate risks where necessary.
3. Deviation & Compliance Management
* Manage deviations associated with validation activities.
* Lead investigation and resolution processes.
* Ensure appropriate documentation and compliance with internal and regulatory requirements.
* Support audit readiness and inspection activities.
Profile Requirements
Experience
* More than 4 years of experience in validation within pharmaceutical or biopharmaceutical environments.
* Strong background in GMP-regulated environments.
* Proven experience in equipment and process validation (IOQ/PQ).
Technical Skills
* Expertise in validation lifecycle management.
* Strong knowledge of risk assessment methodologies.
* Experience working across TRD, Drug Substance, and Drug Product.
* Familiarity with regulatory expectations and quality standards.
Soft Skills
* Strong coordination and project leadership skills.
* Excellent documentation and technical writing abilities.
* Analytical mindset with attention to detail.
* Ability to work cross-functionally in complex project environments.
* Strong communication and stakeholder management skills.
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.