QA Specialist

SIRE LIFE SCIENCES; Breda; On-site; EUR 50,000 - 70,000; Full time

Job summary

A leading pharmaceutical organization in Netherlands is looking for a QA Specialist to provide quality assurance support and oversight for equipment and automation validation. The role requires a Master's degree and at least 3 years of experience in a GMP environment. You will ensure compliance with GMP standards and guide teams on quality policies, contributing to risk management activities and supporting quality engineering. This is an essential position for maintaining high standards in product quality.

Qualifications

• 3+ years of experience in a GMP environment.
• Strong background in equipment and automation validation.
• Proven knowledge of GMP and computer compliance.

Responsibilities

• Perform QA support and oversight for equipment, automation, and IS validation.
• Review and approve validation documentation to meet standards.
• Provide guidance on quality policies and procedures.

Skills

Analytical skills

Communication

Decision-making

Collaboration

Education

Master’s degree in Engineering, Pharmaceutical Sciences, or equivalent

Job description

About the company

Our client is a leading organisation in the pharmaceutical and life sciences sector, committed to delivering high-quality products and ensuring compliance with global standards. They foster innovation and excellence across all operations.

Role description

As a QA Specialist, you will provide quality assurance support and oversight for equipment, automation, and information systems validation. You will play a key role in ensuring compliance with GMP standards and regulatory requirements, while guiding operations teams on quality policies and procedures.

Key responsibilities

• Perform QA support and oversight for equipment, automation, and IS validation.
• Review and approve validation documentation to meet corporate, site, and regulatory standards.
• Provide guidance to operations staff on compliance with quality policies and procedures.
• Support quality engineering activities for testing strategies and investigations.
• Participate in Quality Risk Management activities (pFMEA, QRAES, computer system compliance).
• Review and approve changes to equipment and maintenance procedures.
• Manage device and combination product responsibilities in alignment with GMP regulations.
• Perform final review of technical change controls and ensure completeness of QA assessments.

Requirements

• Master’s degree in Engineering, Pharmaceutical Sciences, Process Technology, or equivalent.
• 3+ years of experience in a GMP environment.
• Strong background in equipment and automation validation.
• Proven knowledge of GMP, computer compliance.
• Experience with risk management tools (e.g., FMEA) and statistical tools for sampling plans and hypothesis testing.
• Excellent analytical, communication, and decision‑making skills.
• Ability to work collaboratively and apply a risk‑based approach.

Other information

Are you interested and do you want to apply for this role? Please fill out your application via the apply button below and contact Margarida Louro.