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.
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