Analytical Compliance Record Specialist

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.

Note:

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

• 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.

• 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 Track Wise.
• 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.

Contact:
Olivier Worch at