QA Validation Specialist Hybrid (GMP/Automation)

Orion Group; Breda; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Orion Group Life Sciences in Breda is seeking a Specialist QA for a multinational client on an initial 12-month contract. The role is hybrid, requiring onsite presence three days per week to support validation, QA systems, and compliance activities.

You will review validation documentation, provide QA guidance to operations, and participate in QRM, change control, and risk assessments to ensure GMP compliance across equipment, automation, and IS.

Qualifications

• Master degree required in Engineering, Pharmaceutical sciences, Process Technology or equivalent.
• 5-8 years of GMP experience preferred.
• Experience with Equipment and Automation Validation.
• Experience with Nonconformances, CAPAs and Change Control.
• Proven experience with GMP, equipment and automation/IS validation, computer compliance (Annex 11, Part 11).
• Proven experience with risk management tools such as FMEA.

Responsibilities

• Perform QA support and oversight for validation of equipment, automation and information systems.
• Review and approve equipment and automation validation documentation.
• Provide guidance to operations staff on quality policies, standards and procedures.
• Provide quality engineering support for testing strategies and quality investigations.
• Lead strategy discussions and approve validation documentation.
• Support maintenance, engineering changes and change controls.
• Manage device responsibilities and ensure GMP alignment.
• Represent QA in QRM activities and ensure policy alignment.
• Perform final review of technical change controls and QA assessments.

Skills

GMP experience

Equipment validation

Automation validation

Quality Risk Management

Change Control

Annex 11/Part 11 compliance

FMEA

Statistical tools

Attention to detail

Communication skills

Education

Master degree in Engineering, Pharmaceutical sciences, Process Technology or equivalent

Job description

Orion Group Life Sciences in Breda is seeking a Specialist QA for a multinational client on an initial 12-month contract. The role is hybrid, requiring onsite presence three days per week to support validation, QA systems, and compliance activities.

You will review validation documentation, provide QA guidance to operations, and participate in QRM, change control, and risk assessments to ensure GMP compliance across equipment, automation, and IS.