Senior QA Validation Engineer – GMP Systems & Compliance

Jobster; Breda; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Competitive salary package

30 holidays

Travel expense reimbursement depending

Contract through Undutchables

Job summary

Jobster in the Netherlands seeks a Senior QA Engineer to lead validation activities for equipment, automation and information systems in a GMP setting. You will guide design, characterization and validation efforts and ensure compliance with EU GMP Annex 11 and FDA Part 11, while coordinating QA input across multiple projects.

Independent and responsible, you will review technical changes, support testing strategies, and align quality activities with corporate policies.

Qualifications

• Master's degree in Engineering, Pharmaceutical Sciences, Process Technology or comparable field.
• Approximately 5–8 years of professional experience within a GMP environment.
• Experience with equipment and automation validation.
• Strong knowledge of GMP requirements.
• Experience with equipment, automation and/or information system validation.
• Knowledge of computerized system compliance requirements, including EU GMP Annex 11 and FDA 21 CFR Part 11.
• Experience with Quality Risk Management tools such as FMEA.
• Experience using statistical methods to support activities such as sampling plans and hypothesis testing.

Responsibilities

• Reviewing and approving equipment, automation and information system validation documentation.
• Providing QA guidance regarding the design, characterization and validation of equipment and systems.
• Ensuring validation activities comply with GMP, internal quality standards and regulatory requirements.
• Reviewing and approving technical changes to equipment, including parameter changes and like-for-like assessments.
• Reviewing changes to Maintenance & Engineering procedures, including preventive and corrective maintenance and changeover processes.
• Providing quality engineering support for testing strategies, investigations and technical quality issues.
• Supporting quality activities related to devices and combination products and ensuring alignment with applicable GMP requirements.
• Representing QA in Quality Risk Management (QRM) activities, including FMEA and other quality risk assessments.
• Reviewing Quality Risk Assessment reports and ensuring site activities remain aligned with corporate quality policies and strategies.
• Performing the final QA review of technical change controls, ensuring assessments and required actions are complete.
• Acting as a QA subject-matter expert for technical changes and coordinating input from different Quality areas.

Skills

Quality engineering

FMEA

Statistical methods

Education

Master's degree in Engineering, Pharmaceutical Sciences, Process Technology

Job description

Jobster in the Netherlands seeks a Senior QA Engineer to lead validation activities for equipment, automation and information systems in a GMP setting. You will guide design, characterization and validation efforts and ensure compliance with EU GMP Annex 11 and FDA Part 11, while coordinating QA input across multiple projects.

Independent and responsible, you will review technical changes, support testing strategies, and align quality activities with corporate policies.