QA Validation Specialist - GMP, Change Control & QRM

People in Science; Breda; On-site; EUR 65,000 - 90,000; Full time

Job summary

People in Science is seeking a QA Specialist – Validation & Quality Systems for an international pharmaceutical manufacturing environment. You will oversee validation activities for equipment, automation and computerized systems, ensuring GMP compliance and alignment with EU GMP Annex 11 and 21 CFR Part 11.

Working with Engineering, Manufacturing, Process Development and IT/IS teams, you will review and approve validation protocols and technical documentation, support Change Controls, and

Qualifications

• Master’s degree in Engineering, Pharmaceutical Sciences, Process Technology, or a comparable technical/scientific discipline.
• 5–8 years of professional experience within a GMP-regulated environment.
• Strong experience with equipment and automation validation.
• Experience with computerized system compliance and EU GMP Annex 11 and 21 CFR Part 11.
• Good understanding of validation principles, qualification and Quality Risk Management.
• Experience with risk management methodologies such as FMEA.
• Experience using statistical tools for sampling plans and hypothesis testing.
• Strong analytical skills and the ability to assess complex technical and quality-related situations.
• Excellent communication and documentation skills.
• Ability to work independently while collaborating effectively with multidisciplinary teams.

Responsibilities

• Provide QA oversight for validation of equipment, automation and computerized/information systems.
• Review and approve validation protocols, reports and other technical documentation.
• Advise on validation strategy, system design and GMP compliance.
• Review and approve technical changes to equipment, parameters and engineering procedures.
• Support Maintenance & Engineering with quality-related assessments for preventive and corrective maintenance activities.
• Act as QA Subject Matter Expert for Change Controls.
• Ensure stakeholder assessments and required actions are documented in Change Controls.
• Represent QA during Quality Risk Management (QRM) activities, including FMEA and other risk assessments.
• Review Quality Risk Assessment reports and ensure alignment with quality requirements.
• Support investigations, testing strategies and other quality engineering activities.
• Support quality requirements related to devices and combination products.

Skills

GMP compliance

Equipment validation

Automation validation

Change controls

Quality risk management

Education

Master's degree

Tools

FMEA

Sampling plans

Hypothesis testing

Job description

People in Science is seeking a QA Specialist – Validation & Quality Systems for an international pharmaceutical manufacturing environment. You will oversee validation activities for equipment, automation and computerized systems, ensuring GMP compliance and alignment with EU GMP Annex 11 and 21 CFR Part 11.

Working with Engineering, Manufacturing, Process Development and IT/IS teams, you will review and approve validation protocols and technical documentation, support Change Controls, and