Senior QA Validation Specialist - GMP & GxP Expert

Jefferson Wells; Maastricht; On-site; EUR 50,000 - 78,000; Full time

Benefits offered by this job

Travel allowance

Pension accrual

Temporary contract through Manpower

Job summary

Jefferson Wells in Maastricht is seeking a QA Validation Specialist to oversee validation activities in a GMP/GxP environment. You will review and approve DQ/IQ/OQ/PQ and URS, and drive validation plans with cross-functional teams.

The role requires a Bachelor’s or Master’s in a relevant field and at least five years of GMP/GxP experience, with strong English and quality-system knowledge. This is a full-time, on-site position with a temporary contract through Manpower.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Biology, Biomedical Sciences, or comparable field.
• Experience in GMP- or GxP-regulated environments is required.
• Experience with Qualification & Validation activities (DQ, IQ, OQ, PQ).
• Knowledge of cGMP, GDP, GAMP, and validation methodologies.
• Experience with deviations, CAPAs, and change control processes.

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.

Skills

Validation

GxP compliance

Quality Assurance

Documentation

Change control

CAPA

GMP

Stakeholder management

Education

Bachelor’s or Master’s degree in Engineering, Life Sciences, Biology, Biomedical Sciences, or comparable field

Job description

Jefferson Wells in Maastricht is seeking a QA Validation Specialist to oversee validation activities in a GMP/GxP environment. You will review and approve DQ/IQ/OQ/PQ and URS, and drive validation plans with cross-functional teams.

The role requires a Bachelor’s or Master’s in a relevant field and at least five years of GMP/GxP experience, with strong English and quality-system knowledge. This is a full-time, on-site position with a temporary contract through Manpower.