Overview
Quality Assurance Specialist Jobs in Leiden, South Holland, Netherlands at Meet Life Sciences
Title: Quality Assurance Specialist
Company: Meet Life Sciences
Location: Leiden, South Holland, Netherlands
Quality Assurance Consultant
Meet Life Sciences are supporting a leading pharmaceutical organisation as they look to bring in an experienced QA Consultant to support a number of critical quality and compliance initiatives across their manufacturing operations.
This opportunity will suit a consultant with a strong background in GMP Quality Assurance who is comfortable operating across complex quality systems, stakeholder management, compliance activities and continuous improvement projects.
Location: Leiden, Netherlands
Start Date: ASAP
Industry: Pharmaceutical Manufacturing
Environment: EU GMP-Regulated
Key Responsibilities:
- Lead and support complex Deviation Investigations, CAPAs and Change Controls
- Drive Quality Management System (QMS) improvements and compliance initiatives
- Review and approve GMP Documentation, SOPs, Protocols and Reports
- Support Internal Audits, Supplier Audits and Regulatory Inspection Readiness activities
- Partner with Manufacturing, Quality Control and Technical Operations teams to resolve quality and compliance issues
- Perform Gap Assessments against EU GMP requirements and support remediation activities
- Provide QA Oversight across manufacturing and operational quality processes
- Support Quality Risk Management (QRM) activities and continuous improvement programmes
Requirements:
- Proven experience within GMP Quality Assurance in the pharmaceutical or biotechnology industry
- Strong background in Deviations, CAPAs, Change Controls and QMS Management
- Experience supporting Regulatory Inspections and Audit Activities
- Excellent knowledge of EU GMP requirements
- Ability to influence stakeholders and drive quality improvements across multiple functions
- Previous experience working as a Consultant or Contractor is highly desirable
- Experience within Sterile Manufacturing, Biologics, ATMPs, Vaccines or Commercial Pharmaceutical Manufacturing would be advantageous
- Fluent English required
If this sounds like a role that suits you, apply directly or feel free to contact me at [email protected].