Quality Assurance Specialist – Pharmaceutical Industry

About the role

Join Nalys as a Quality Assurance Specialist supporting pharmaceutical and biotech clients in Belgium. This hands‑on position focuses on deviation management, GMP compliance, and utilities oversight, with up to one remote day per week.

Key responsibilities

• Lead and support the full lifecycle of deviations, investigations, and change controls.
• Produce investigation documentation that meets audit and inspection standards.
• Perform quality oversight on GMP documentation and technical operations, especially utilities systems.
• Collaborate with engineering and technical teams to ensure rigorous follow‑up of investigations.
• Contribute to internal audits, compliance activities, and inspection readiness.
• Monitor quality indicators and drive continuous‑improvement initiatives.
• Participate in periodic quality reviews, system reviews, and utilities monitoring reports.
• Provide QA support for qualification, validation, and utilities‑related projects.

Required profile

• Minimum 5 years of experience in a QA role within a regulated pharmaceutical or GMP environment.
• Proven track record in deviation management, root‑cause analysis, and CAPA processes.
• Excellent documentation and technical writing skills for investigation reports.
• Fluent in English and French.
• Autonomous, structured, and able to manage multiple priorities.
• Experience with Quality Management Systems, auditing, or utilities/cleanroom environments is a strong asset.

Required skills

• Deviation management
• Investigation documentation
• Change control
• GMP compliance
• Root‑cause analysis
• CAPA implementation
• Quality Management Systems
• Auditing
• Utilities systems oversight
• Qualification and validation processes

What we offer

• Human‑scaled consulting environment focused on expertise and career development.
• Long‑term assignments with leading pharmaceutical players.
• Continuous learning through technical coaching, training, and knowledge sharing.
• Supportive culture valuing autonomy, trust, and impact.
• Attractive salary package with additional benefits.