Audit & Inspection Compliance, Utrecht, Utrecht

The Company
An international life sciences organization focused on high?quality healthcare products. The company offers a collaborative environment, modern digital tools, and the opportunity to work with global stakeholders across quality, compliance, and product development.

Job Description 
As a Quality & Compliance Support Specialist, you will assist with audits, inspections, SOP and document management, and process maintenance activities. You will work closely with process owners, PV experts, and global teams to ensure accurate documentation, regulatory compliance, and smooth operational workflows.

Responsibilities  
- Coordinate internal audits, partner audits, and health authority inspections. 
- Maintain audit and inspection trackers, action lists, and timelines. 
- Support scheduling of inspections, meetings, interviews, and readiness activities. 
- Prepare documentation, coordinate responses, and support corrective actions. 
- Track and manage audit commitments in collaboration with process owners. 
- Support inspection preparation activities and maintain repositories and trackers. 
- Maintain selected SOPs, WIs, and templates that fall under GDS&PV Compliance ownership. 
- Manage document updates, reviews, and approvals. 
- Track review cycles and coordinate with relevant stakeholders. 
- Ensure correct formatting, consistency, and compliance with internal standards. 
- Act as an operational point of contact for process?related questions.

Requirements 
- Bachelor’s degree or equivalent, with 5+ years of experience in a regulated industry. 
- Strong understanding of regulatory guidelines and policies for drug safety and pharmacovigilance. - Experience working under deadlines and managing multiple priorities. 
- Excellent communication skills in written and spoken English. 
- Experience with modern document management systems. 
- Previous work in cross?functional and international teams. 
- Ability to handle pressure in fast?paced environments. 
- Strong organizational and stakeholder?management skills. 

Other Information 
Are you interested and do you want to apply for this role? Please fill out your application via the apply button below.

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