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Proclinical
Analytical Compliance Record SpecialistProclinical • Basel, Switzerland
Analytical Compliance Record Specialist

Analytical Compliance Record Specialist

Proclinical • Basel, Switzerland
Vor 4 Tagen
Stellenbeschreibung

Ensure cGMP excellence by safeguarding analytical compliance in a world‑class Swiss quality organization.

Proclinical is seeking an Analytical Compliance Record Specialist to join a quality-focused team in Switzerland. This role involves working within a modern quality control organization to ensure compliance with cGMP regulations. You will play a key role in managing compliance records, facilitating root cause analyses, and supporting inspections. This is an exciting opportunity for individuals passionate about quality assurance in the pharmaceutical industry.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

  • Manage compliance records for the department, including deviations, changes, and CAPAs.
  • Collaborate with stakeholders such as QA, scientists, and senior management.
  • Facilitate and document root cause analyses.
  • Actively participate in quality review boards and other strategic governing bodies.
  • Support inspections by preparing and presenting records to internal and external auditors.
  • Critically evaluate work results to ensure high standards.
  • Maintain and enhance GMP compliance within the department.
  • Document scientific and regulatory work accurately.

Key Skills and Requirements:

  • A university degree (Bachelor's, Master's, or higher) in a relevant natural science field (e.g., Chemistry, Pharmacy, Biology).
  • Alternatively, candidates with a laboratory technician background and over 10 years of high-level GMP experience will be considered.
  • 3-5 years of professional experience in a regulated pharmaceutical or biotech environment.
  • Hands-on experience working under cGMP regulations is mandatory. Proficiency in Quality Management Systems such as Veeva Vault or TrackWise.
  • Demonstrated ability to manage compliance records, including deviations, change control, and CAPAs.
  • Business fluency in English (written and spoken) for documentation and stakeholder management.
  • Proficiency in German is a strong asset.
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Analytical Compliance Record Specialist • Basel, Switzerland

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