Quality Validation specialist

NES Fircroft; Breda; Hybrid; EUR 64,000 - 67,000; Full time

Job summary

NES Fircroft seeks a Senior Quality Validation professional to oversee validation of equipment, automation and information systems, and to drive Quality Risk Management. Hybrid role in a multinational environment with 12-month contract and potential renewal.

Responsibilities include QA oversight, document reviews, risk assessments, and change control coordination to ensure GMP compliance across the site and regulatory requirements.

Qualifications

• Master's degree in Engineering, Pharmaceutical Sciences, Process Technology, or related discipline.
• 4–8 years of GMP-regulated pharma experience.
• Hands-on validation with equipment, automation, and information systems.
• Strong GMP and 21 CFR Part 11 knowledge.
• Experience with Quality Risk Management (FMEA).

Responsibilities

• Provide QA oversight and support for equipment, automation, information systems validation, and Quality Risk Management activities.
• Review and approve validation documentation, ensuring compliance with GMP, corporate, site, and regulatory requirements.
• Define validation strategies and provide guidance on equipment, process, automation, and system design, characterization, and validation.
• Review and approve equipment changes, parameter modifications, and engineering assessments.
• Review and approve Maintenance & Engineering procedures, including preventive and corrective maintenance processes.
• Manage device and combination product quality responsibilities and ensure compliance with GMP regulations.
• Represent QA in Quality Risk Management activities, including pFMEA, risk assessments, and computer system compliance reviews.
• Review and approve quality risk assessments and ensure alignment with corporate quality policies and strategies.
• Perform final QA review of technical change controls and coordinate QA input for change assessments.
• Support quality investigations, testing strategies, and operational teams on quality standards, policies, and procedures.

Skills

QA oversight

Validation

Risk assessment

Documentation review

GMP knowledge

Education

Master's degree in Engineering/Pharma

Job description

o you want to be part of a world wide organization recognized as World's Best Workplace with the mission of saving patients through advanced biotech technologies?

Our client's products reach over 10 million patients worldwide, that is why we are supporting them in looking for a Senior Quality Validation to oversight for validation of equipment, automation and information systems and for Quality Risk Management.

Contract Length: 12 months (possibility of renewal)

Hybrid: Hybrid attendance – 40h per week

Salary Range: €5700 - 6000 EUR/gross a month

Responsibilities

• Provide QA oversight and support for equipment, automation, information systems validation, and Quality Risk Management activities.
• Review and approve validation documentation, ensuring compliance with GMP, corporate, site, and regulatory requirements.
• Define validation strategies and provide guidance on equipment, process, automation, and system design, characterization, and validation.
• Review and approve equipment changes, parameter modifications, and engineering assessments.
• Review and approve Maintenance & Engineering procedures, including preventive and corrective maintenance processes.
• Manage device and combination product quality responsibilities and ensure compliance with GMP regulations.
• Represent QA in Quality Risk Management activities, including pFMEA, risk assessments, and computer system compliance reviews.
• Review and approve quality risk assessments and ensure alignment with corporate quality policies and strategies.
• Perform final QA review of technical change controls and coordinate QA input for change assessments.
• Support quality investigations, testing strategies, and operational teams on quality standards, policies, and procedures.

Requirements

• Master's degree in Engineering, Pharmaceutical Sciences, Process Technology, or a related discipline.
• 4-8 years of experience in a GMP-regulated pharmaceutical or life sciences environment.
• Hands-on experience with equipment, automation, and information systems validation.
• Strong knowledge of GMP regulations and computerized system compliance requirements (e.g., Annex 11, 21 CFR Part 11).
• Experience with Quality Risk Management tools, including FMEA and other risk assessment methodologies.