QA Qualification Engineer

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

• 12 months
• Full Time
• Onsite in North 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.