Quality Release Specialist
Quality Release Specialist for a global life-sciences client, on-site in Haarlem, supporting batch release in a GMP environment.
- Locatie
- Haarlem
- Werkvorm
- op locatie
- Sluitingsdatum
Eisen
- Strong communication skills in Dutch and English (written and spoken)
- Collaborative mindset with strong accuracy, ownership, and stakeholder management skills
- Comfortable reviewing and approving GMP documentation (e.g., SOPs, deviations, validation/qualification records, change controls)
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemical Engineering, Process Technology, or a related field
Wensen
- Relevant experience in a GMP environment (Quality Assurance and/or batch release activities preferred)
- Experience with packaging technology and/or Quality Control is a plus
- Experience with SAP is a plus
Volledige omschrijving
Company: Our client is a global, highly regulated life-sciences organization with a large-scale packaging and distribution site. The location operates within a robust GMP environment and works closely with cross-functional teams to ensure products are released safely, compliantly, and on time for international supply.
Job Description: The Quality Release Specialist supports batch release and quality oversight activities within a busy vaccines/packaging environment. The role focuses on ensuring GMP documentation and quality processes are followed correctly, supporting investigations and continuous improvement, and partnering closely with Operations, Quality Control, and validation stakeholders.
Responsibilities: Review and support deviation investigations, including root cause analysis and follow-up actions (CAPAs). Support the handling and investigation of market complaints in collaboration with relevant stakeholders. Contribute to strengthening quality awareness across the site through active collaboration and coaching. Participate in cross-functional projects as the Quality representative, supporting implementation of quality requirements.
Support departments with the correct application of quality systems (including GMP) and changes to procedures/guidelines. Contribute to new product introductions, ensuring quality aspects are addressed from start to finish. Review and approve key GMP documents such as SOPs, change controls, and qualification/validation documentation. Work closely with packaging teams, Quality Control, and other quality functions to enable compliant, timely release activities.
Requirements: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemical Engineering, Process Technology, or a related field. Relevant experience in a GMP environment (Quality Assurance and/or batch release activities preferred). Comfortable reviewing and approving GMP documentation (e.g., SOPs, deviations, validation/qualification records, change controls). Strong communication skills in Dutch and English (written and spoken). Collaborative mindset with strong accuracy, ownership, and stakeholder management skills.
Experience with packaging technology and/or Quality Control is a plus. Experience with SAP is a plus.
Other Information: This position is based on-site and offers the chance to work in a quality-focused environment with significant cross-department collaboration and responsibility for GMP compliance and product release readiness.
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