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Quality Compliance Specialist

Quality Compliance Specialist

Quality Compliance Specialist

Quality Compliance Specialist

Swisslinx

Pharma, Medizintechnik

Neuenburg

  • Art der Beschäftigung: Vollzeit
  • 88.000 CHF – 118.000 CHF (von XING geschätzt)
  • Vor Ort
  • Zu den Ersten gehören

Quality Compliance Specialist

Über diesen Job

We are currently looking for an experienced Quality Compliance Specialist to join the Quality organization of a leading biopharmaceutical company…

Quality Compliance Specialist
Job description:

We are currently looking for an experienced Quality Compliance Specialist to join the Quality organization of a leading biopharmaceutical company in Neuchatel. In this role, you will be part of the Quality Compliance & Systems team and play a key role in GMP self-inspections, data integrity, and inspection readiness activities.

This is an exciting opportunity for a senior QA professional who enjoys cross-functional collaboration, audit environments, and driving continuous improvement within a GMP-regulated setting.

About the customer:

End: 31.08.2026 with possible extension

Requirements:
  • Act as QA representative for routine GMP Self-Inspection activities
  • Maintain and continuously improve the self-inspection system
  • Define and implement a risk-based self-inspection schedule in collaboration with site leadership
  • Plan, coordinate and support internal, corporate and external GMP audits
  • Participate as backroom (ACC) or Scribe member during audits
  • Perform gap assessments on new or revised global procedures
  • Ensure inspection readiness across departments including Production, QC, Warehouse and Engineering
  • Deliver coaching sessions to SMEs and audit teams
  • Act as local Data Integrity Champion and ensure strong collaboration with global teams
  • Prepare, analyse and present compliance topics at Quality Council
  • Support continuous improvement initiatives within the compliance team
  • Act as back-up to the Head of Quality Compliance & Systems when required
  • Ensure adherence to EHS guidelines and promote a strong safety culture
Competences:
  • University degree in a scientific or technical discipline such as Biochemistry, Chemistry or Engineering
  • Minimum 7 years of experience in the biotechnology and or pharmaceutical industry
  • Strong knowledge of GMP environments
  • Good understanding of manufacturing, laboratory testing and warehousing operations related to biological products
  • Solid knowledge of GDDP and Data Integrity principles
  • Experience in creating, reviewing and revising SOPs and technical documentation
  • Experience supporting regulatory inspections and audits
  • Familiarity with risk management tools such as FMEA and root cause analysis
  • Proficiency in French and English (minimum B2 level)
  • Experience with electronic quality management systems such as Veeva Vault or TrackWise
  • Strong MS Office skills and experience with reporting tools such as Power BI

Gehalts-Prognose

Unternehmens-Details

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Swisslinx

Personaldienstleistungen und -beratung

11-50 Mitarbeitende

Zürich, Schweiz

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