GMP Specialist - Quality systems

GMP Specialist – Quality Systems (Junior)

Purpose of the Role

Supports the maintenance and continuous improvement of core GMP Quality Systems to ensure compliance with regulatory requirements and internal standards. Contributes to inspection readiness and consistent application of quality processes across departments.

Key Responsibilities

• Support the maintenance and improvement of GMP core quality systems to ensure compliance and efficiency.
• Assist in keeping procedures, specifications, and documentation up to date.
• Contribute to inspection readiness activities and support audit preparation and follow-up actions.
• Participate in internal audits as a team member and assist in tracking corrective and preventive actions (CAPAs).
• Support implementation of compliance and process improvement initiatives.
• Apply basic risk management and process improvement principles when assessing quality processes.
• Assist in coordinating GMP training activities related to quality systems.
• Act as a contact point for routine quality systems questions within the department.
• Support preparation of quality metrics and compliance reports.
• Ensure effective communication with relevant departments regarding quality system updates.

Scope & Complexity

The role operates in a regulated pharmaceutical environment and supports the compliance of core quality systems. The position requires analytical thinking, attention to detail, and the ability to work in a structured and multidisciplinary setting. More complex decisions are escalated to senior team members.

Minimum Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Engineering, or a related field.
• 0–2 years of experience in a pharmaceutical or regulated environment (internships included).
• Basic knowledge of GMP and quality systems.
• Strong analytical skills and attention to detail.
• Good written and verbal communication skills in Dutch and English.
• Proactive mindset and willingness to learn.