GMP QA Validation Specialist — Impactful Compliance Expert

Jobster; Geleen; On-site; EUR 50,000 - 78,000; Full time

Benefits offered by this job

Travel allowance €0.23 per kilometer

Pension accrual

Full-time 40 hours per week

Job summary

Manpower and its international pharmaceutical client seek a QA Validation Specialist in Maastricht to oversee GMP-compliant validation activities. You will review, approve, and maintain qualification plans, collaborate with QA, Engineering, Production and Technical Services, and ensure traceability across lifecycle documentation.

In this role you’ll perform risk assessments, approve validation reports, and support changes to equipment, facilities, and processes, contributing to quality, safety

Qualifications

• Experience with qualification and validation projects.
• Ability to review, approve, and oversee validation activities.
• Familiarity with GMP, GxP, GDP and quality requirements.

Responsibilities

• Reviewing and approving validation and qualification documentation (DQ, IQ, OQ, and PQ)
• Assessing and approving User Requirement Specifications (URS)
• Preparing, reviewing, and maintaining validation and qualification plans
• Performing and evaluating risk assessments for equipment, facilities, and utilities
• Approving FAT, SAT, commissioning, and validation reports
• Ensuring full traceability throughout validation projects
• Managing and reviewing lifecycle documentation for equipment and installations
• Conducting periodic reviews of validated GxP systems, equipment, and utilities
• Performing impact assessments for changes to equipment, facilities, and processes
• Supporting production and technical departments with validation activities
• Managing deviations, change controls, and CAPA processes
• Ensuring compliance with GMP, GxP, GDP, and quality requirements
• Providing advice on quality and compliance-related matters
• Identifying and implementing improvements within validation and quality systems
• Collaborating with QA, Engineering, Production, and Technical Services to ensure compliance

Job description

Manpower and its international pharmaceutical client seek a QA Validation Specialist in Maastricht to oversee GMP-compliant validation activities. You will review, approve, and maintain qualification plans, collaborate with QA, Engineering, Production and Technical Services, and ensure traceability across lifecycle documentation.

In this role you’ll perform risk assessments, approve validation reports, and support changes to equipment, facilities, and processes, contributing to quality, safety