QA Qualification Engineer

Il y a 3 jours

Beerse, Antwerpen, Belgique EPM Scientific Temps plein 60 000 € - 90 000 € Contrat

Gratuit avec email ou Google

Enregistrez cette offre et organisez votre recherche

Créez un compte gratuit pour enregistrer des offres d'emploi, créer des alertes et revenir à cette liste depuis votre tableau de bord.

Gratuit avec email ou Google

EPM Scientific are supporting a leading Pharmaceutical client on their search for a Freelance QA Qualification Engineer in Northern Belgium.

Provide QA support with a primary focus on facilities and utilities (e.g. HVAC, water systems, gas systems).
Participate in change projects throughout the entire system lifecycle.
Review and approve qualification deliverables including:
Ensure compliance with applicable regulations, industry guidelines, and company policies and standards.
- User Requirements Specifications (URS)
- Risk Assessments
- DQ / IQ / OQ / PQ Protocols
- Test Scripts
- Qualification Reports
Review and approve procedures related to:
- Qualification
- Calibration
- Maintenance
- Lifecycle Management of Systems
Ensure that deviations related to systems (qualification, maintenance, calibration and/or use) with potential impact on quality and/or compliance are:
- Appropriately assessed
- Thoroughly investigated
- Effectively addressed through adequate corrective and preventive actions.
Maintain a current understanding of applicable international regulations, guidelines and industry practices related to system qualification, and apply this knowledge to continuously improve qualification processes.
Support regulatory inspections, customer audits and internal compliance assessments by ensuring audit readiness and providing subject matter expertise on qualification-related topics.
Collaborate closely with cross-functional stakeholders involved in qualification and lifecycle management activities to ensure project timelines are achieved and organisational objectives are met.

Strong QA professional with experience in a regulated environment.
Experience in QA oversight of facilities and utilities is preferred, although candidates with a strong interest in this area are also encouraged.
Strong quality and compliance mindset.
Strong communication skills.
Ability to challenge constructively while maintaining positive and productive relationships with stakeholders.