Specialist QA

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

QA Specialist – Validation & Quality Systems

Are you an experienced QA professional with a strong background in equipment, automation and computerized system validation? For an international pharmaceutical manufacturing environment, we are looking for a QA Specialist who will provide quality oversight across technical projects, validation activities and Quality Risk Management.

In this role, you will work closely with Engineering, Manufacturing, Process Development and IT/IS teams. You will ensure that equipment, automated systems and technical changes meet GMP requirements as well as internal and regulatory quality standards.

Your role

As a QA Specialist, you will act as the Quality representative for validation, engineering and technical change activities. You will review and approve documentation, provide guidance on compliance requirements and support teams in making risk-based quality decisions.

• Providing QA oversight for the validation of equipment, automation and computerized/information systems;
• Reviewing and approving validation protocols, reports and other technical documentation;
• Advising project and operational teams on validation strategy, system design and GMP compliance;
• Reviewing and approving technical changes to equipment, parameters and engineering procedures;
• Supporting Maintenance & Engineering with quality-related assessments for preventive and corrective maintenance activities;
• Acting as QA Subject Matter Expert for technical Change Controls;
• Ensuring that stakeholder assessments and required actions within Change Controls are complete and correctly documented;
• Representing QA during Quality Risk Management (QRM) activities, including FMEA and other risk assessments;
• Reviewing Quality Risk Assessment reports and ensuring alignment with site and corporate quality requirements;
• Supporting investigations, testing strategies and other quality engineering activities;
• Supporting quality requirements related to devices and combination products.

You will work independently across multiple projects and assignments, determining the appropriate quality approach while ensuring agreed objectives and timelines are achieved.

What you bring

• A Master’s degree in Engineering, Pharmaceutical Sciences, Process Technology or a comparable technical/scientific discipline;
• Approximately 5–8 years of professional experience within a GMP-regulated environment;
• Strong experience with equipment and automation validation;
• Experience with computerized system compliance and relevant regulations such as 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 to support activities such as sampling plans and hypothesis testing;
• Strong analytical skills and the ability to assess complex technical and quality-related situations;
• Excellent communication and documentation skills;
• The ability to work independently while collaborating effectively with multidisciplinary teams.

Experience within the pharmaceutical industry and knowledge of deviations/nonconformances, CAPA and Change Control are considered strong advantages.

What makes you successful in this role?

You are able to maintain a broad overview while diving into technical details when necessary. You combine strong quality awareness with a pragmatic and risk-based mindset and are comfortable challenging, advising and supporting stakeholders across different departments. You enjoy working in a highly regulated environment where quality, patient safety and continuous improvement are central to everything you do.