Quality Release Specialist
SIRE® Life Sciences
Quality Release Specialist
Samenvatting
Wat krijg je?
Wat ga je doen?
- Afwijkingsonderzoeken en CAPA's ondersteunen
- Klachten uit de markt afhandelen
- Kwaliteitsbewustzijn op de site versterken
- Deelnemen aan diverse projectteams
- Kwaliteitssystemen en GMP-richtlijnen toepassen
Wat verwachten wij?
- Degree in Pharmacy, Life Sciences or Chemical Engineering
- Experience in a Quality Assurance GMP environment
- Experience reviewing and approving complex GMP documentation
- Experience with packaging technology or Quality Control (pre)
Volledige vacaturetekst
At this global life-sciences leader, you will play a vital role in the safe release of vaccines within a large-scale packaging site. You will drive quality excellence by partnering with cross-functional teams on investigations and continuous improvement projects. Enjoy the unique opportunity to contribute to new product introductions while coaching others to strengthen site-wide quality awareness. Ready to make a real impact on international healthcare? Explore the full details and apply now.
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.
If you are interested and want to apply, please submit your application via the apply button below and contact me.
59198
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