Company
Our client is a leading organisation in the pharmaceutical and life sciences sector, operating in a highly regulated environment where quality, safety, and compliance are critical. The site supports ongoing improvement and investment projects, requiring strong coordination between engineering, quality, and safety stakeholders. The organisation offers a professional setting with multiple projects running in parallel and a strong focus on documented ways of working.
Job Description
For our client in Haarlem, we are looking for a Quality Change Control & Commissioning Specialist. This role focuses on managing and coordinating changes within quality and safety systems, ensuring each change is properly assessed, approved, documented, and closed. In addition, the specialist supports commissioning activities for facility infrastructure and technical assets in a live operational environment.
Responsibilities
- Lead and coordinate the full change control process from initiation through approval, follow-up, and closure.
- Perform pre-assessments and impact assessments to determine how proposed changes may affect GMP processes, safety, operations, and related documentation.
- Work closely with stakeholders such as Quality, Safety, Engineering, and technical asset owners to collect input and align on next steps.
- Ensure change records are complete, accurate, and traceable, with clear supporting documentation.
- Support commissioning activities related to facility and utility assets (e.g., HVAC, utilities, and fire safety systems), including coordination of required information and alignment with internal teams.
- Track progress across multiple ongoing projects and keep actions moving in a structured and timely way.
Requirements
- Proven experience with change control / change management in a regulated environment (preferably GMP).
- Experience working with quality and safety systems (experience with Veeva is a strong advantage).
- Comfortable performing impact assessments and coordinating approvals with multiple stakeholders.
- Strong documentation skills and a structured, detail-focused way of working.
- Able to work independently, take ownership, and communicate clearly with both technical and non-technical colleagues.
- Fluent in English (Dutch is a plus).
Other Information
The role is based in Haarlem and involves close collaboration with on-site stakeholders in Quality, Safety, and Engineering. Hybrid working may be possible depending on the project needs and team agreements.
If you are interested and want to apply, please submit your application via the apply button below and contact me.
59369
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Jyothi Shiva
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