About the Company
Our client is a large, highly regulated life-sciences organisation with an active site in the Netherlands. With many facility and engineering projects running at the same time, the business relies on strong change control, clear documentation, and close collaboration between Engineering, Quality, Safety, and operations.
Role Description
We are looking for a Quality Change Control & Commissioning Specialist. This role leads change control activities within quality and safety systems and supports commissioning work for facility infrastructure and technical assets. The Quality Change Control & Commissioning Specialist will coordinate impact assessments, drive stakeholder alignment, and ensure change records are followed through from initiation to closure in a live operational environment.
Responsibilities
-Initiate, manage, track, and close change control records within quality and safety systems.
-Perform pre-assessments and impact assessments for engineering and facility changes.
-Evaluate potential impact on GMP-relevant processes, safety, operations, and supporting documentation.
-Coordinate information gathering, reviews, approvals, and follow-up actions with Quality, Safety, Engineering, and technical asset owners.
-Maintain accurate, complete, and audit-ready change documentation.
-Support commissioning activities for facility infrastructure and technical assets (e.g., HVAC, utilities, electrical systems, fire safety systems, and building finishes such as floors, walls, and ceilings).
-Manage priorities effectively across multiple concurrent projects and stakeholders.
Requirements
-Strong experience in change control / change management, ideally in a GMP-regulated environment.
-Experience working with quality and safety management systems; familiarity with electronic quality systems (e.g., Veeva-type tools) is a strong advantage.
-Solid background in impact assessment and structured documentation management.
-Confident stakeholder manager who can work independently and take ownership.
-Fluent English; Dutch is a plus.
Other Information
If you are interested and want to apply, please submit your application via the apply button below and contact me.
59410
Share This Job
Windimi Post
Similar projects
Supply Network Planner
Sector: Food
⚙️Ref: 59417Temporary
QA Validation Specialist
Sector: Food
⚙️Ref: 59416Temporary
Validation & Food Safety QA Specialist
Sector: Food
⚙️Ref: 59415Temporary
Manufacturing Operator
Sector: Food
⚙️Ref: 59414Temporary
Supply Chain Project Manager
Sector: Food
⚙️Ref: 59413Temporary
Project Manager (BioPharma Engineering)
Sector: Pharmaceuticals
⚙️Ref: 59412Temporary
QA Validation Specialist
Sector: Food
⚙️Ref: 59383Temporary
Microbiology Technician
Sector: Biotechnology
⚙️Ref: 59409Temporary
Validation & Calibration Engineer
Sector: Pharmaceuticals
⚙️Ref: 59408Temporary
Maintenance Work Preparation Coordinator
Sector: Pharmaceuticals
⚙️Ref: 59407Temporary