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Quality Compliance Specialist

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Proclinical

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Location:
Switzerland , Neuchâtel

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Proclinical is seeking a Quality Compliance Specialist to join the Quality organization at a facility in Neuchâtel. This role focuses on GMP self-inspection activities, data integrity, and quality project deployment. You will collaborate across departments to ensure compliance with internal standards and regulatory expectations while promoting continuous improvement initiatives.

Job Responsibility:

  • Manage and improve the GMP self-inspection system, including planning, execution, and supporting lead auditors
  • Deliver coaching sessions to SMEs and audit teams for inspection readiness
  • Define and implement risk-based self-inspection schedules in collaboration with site leadership
  • Perform gap assessments on new or revised global procedures
  • Coordinate with various departments to ensure alignment and communication
  • Benchmark best practices within the broader Biologics network
  • Support GMP audits by reviewing documents and providing QA input
  • Act as a backroom ACC team member or scribe during audits
  • Prepare and present compliance-related topics at the Quality Council
  • Serve as the local data integrity champion, ensuring adherence to principles through collaboration with global teams
  • Provide compliance support to partners and act as a backup for the Head of Quality Compliance and Systems when needed

Requirements:

  • University degree in a technical or scientific discipline (e.g., biochemistry, chemistry, engineering)
  • Strong knowledge of GMP environments and Good Data and Documentation Practices (GDDP)
  • Familiarity with manufacturing, laboratory testing, and warehousing operations for biological products
  • Experience creating, reviewing, and revising SOPs and technical documents
  • Proficiency in French and English (minimum B2 level)
  • Proficiency in electronic quality management systems (e.g., Veeva Vault, TrackWise) and Microsoft Office tools
  • Knowledge of risk management tools and methodologies (e.g., FMEA, root cause analysis)
  • Experience supporting regulatory inspections and audits

Additional Information:

Job Posted:
March 04, 2026

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