Senior QA Validation Specialist - GMP & Compliance

Manpower; Maastricht; On-site; EUR 54,000 - 84,000; Full time

Benefits offered by this job

Travel allowance

Pension accrual

Full-time 40 hours

Temporary contract through Manpower

Professional development opportunities

Job summary

Manpower in Maastricht is seeking a QA Validation Specialist to lead qualification and validation projects within a GMP/GxP framework. You’ll review DQ/IQ/OQ/PQ packages and maintain comprehensive validation records across equipment and facilities.

Role involves cross-functional collaboration with QA, Engineering and Production, delivering high-quality compliant outcomes and ongoing improvements. Fluency in English is required; five years in regulated settings preferred.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Biology, Biomedical Sciences, or a comparable field.
• At least five years of experience within a GMP- or GxP-regulated environment.
• Experience with Qualification & Validation activities (DQ, IQ, OQ, and PQ).
• Knowledge of cGMP, GDP, GAMP, and validation methodologies.
• Experience with deviations, CAPAs, and change control processes.
• Experience with equipment, facility, and utility validation.
• Excellent command of the English language, both written and spoken.
• Experience with quality management systems and compliance requirements within the pharmaceutical or life sciences industry.

Responsibilities

• Reviewing and approving validation and qualification documentation (DQ, IQ, OQ, and PQ).
• Assessing and approving User Requirements 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.

Skills

GMP compliance

Validation management

Documentation review

Cross-functional collaboration

Risk assessment

Education

Bachelor’s or Master’s in Engineering/Life Sciences/Biology/Biomedical Sciences

Job description

Manpower in Maastricht is seeking a QA Validation Specialist to lead qualification and validation projects within a GMP/GxP framework. You’ll review DQ/IQ/OQ/PQ packages and maintain comprehensive validation records across equipment and facilities.

Role involves cross-functional collaboration with QA, Engineering and Production, delivering high-quality compliant outcomes and ongoing improvements. Fluency in English is required; five years in regulated settings preferred.