QA Operations Specialist

Responsibilities

STAR Life Sciences is currently looking for a QA Operations Specialist on behalf of an internationally operating pharmaceutical company located in the Breda region.

In this position, you will support a wide range of GMP-related quality assurance activities within a manufacturing environment. Your primary focus will be ensuring the timely and compliant release of production batches while maintaining the site's Quality Management System in accordance with GMP regulations and applicable industry standards.

You will work closely with cross-functional teams and play an important role in maintaining product quality and driving continuous improvement initiatives.

Location: Breda region, The Netherlands.

Important: Applicants must currently reside in the Netherlands and already have the legal right to work in the Netherlands. Unfortunately, visa sponsorship or work permit support is not available for this position.

Key Responsibilities

• Perform QA reviews of batch documentation and support the batch release process.
• Provide on-site QA support during manufacturing activities and operational interventions.
• Manage the document lifecycle in both paper-based and electronic quality systems, including batch record archiving.
• Release incoming materials and starting materials.
• Perform visual monitoring activities and support surprise on-site quality inspections.
• Review and approve quality documentation, including SOPs, protocols and work instructions.
• Support deviation management by ensuring timely impact assessments, investigations and closure.
• Review and approve investigations related to Out of Specification (OOS), Out of Trend (OOT), Out of Expectation (OOE) results and System Suitability Test failures.
• Support CAPA implementation and ensure timely execution of corrective and preventive actions.
• Support change control activities and implementation of associated actions.
• Assist in the preparation and execution of internal audits and regulatory inspections.
• Contribute to continuous improvement and quality enhancement projects.

What we're looking for

• MBO or Bachelor's degree (HBO) in Life Sciences, Laboratory Science, Pharmacy, Biotechnology, Chemistry or another relevant scientific discipline.
• Experience working in a GMP-regulated environment.
• Good understanding of Quality Management Systems and pharmaceutical quality regulations.
• Strong attention to detail and excellent organizational skills.
• Ability to prioritize work and perform effectively under time pressure.
• A proactive, solution-oriented mindset with sound judgement and a quality-first approach.
• Strong communication skills and the ability to work effectively in multidisciplinary teams.
• Fluent English, both written and spoken.

Requirements

Preferred Qualifications

• Experience with radiopharmaceuticals, PET manufacturing or radiation-controlled environments.
• Experience supporting inspections, audits and continuous improvement initiatives.

What we offer
Through STAR Life Sciences, you will join an innovative international pharmaceutical organization in the Breda region, where quality, collaboration and continuous improvement are at the heart of daily operations. 

You will have the opportunity to work in a highly regulated GMP environment with a varied and challenging range of responsibilities while receiving personal guidance from our dedicated Life Sciences recruitment team. We offer long-term career opportunities, professional support and access to an extensive network within the Dutch Life Sciences industry.