QA Qualification Engineer

EPM Scientific; Beerse; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

EPM Scientific is supporting a leading pharmaceutical client in Northern Belgium to recruit a Freelance QA Qualification Engineer for a 12-month, full-time onsite assignment. The role focuses on facilities and utilities qualification, with oversight of URS, IQ/OQ/PQ, risk assessments and related change projects.

You will interact with cross-functional teams and support regulatory inspections to ensure compliance.

Qualifications

• 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 encouraged.
• Strong quality and compliance mindset.
• Strong communication skills.
• Ability to challenge constructively while maintaining positive and productive relationships with stakeholders.

Responsabilités

• 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 URS, risk assessments, DQ/IQ/OQ/PQ protocols, test scripts and qualification reports.
• Review and approve procedures related to qualification, calibration, maintenance and lifecycle management of systems.
• Ensure deviations related to systems with potential impact on quality and/or compliance are properly assessed, investigated and followed up with CAPA.
• Maintain up-to-date knowledge of applicable international regulations and guidelines to improve qualification processes.
• Support regulatory inspections, customer audits and internal compliance assessments by ensuring audit readiness.

Connaissances

QA experience

Regulated environment

Communication skills

Stakeholder management

Description du poste

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

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

QA Qualification Engineer

• 12 months
• Full Time
• Onsite in North Belgium

Job Description

Main Responsibilities

• 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.
  

Profile Required

• 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.