Analytical Compliance Record Specialist

Be the quality anchor ensuring inspection‑ready analytical operations in a modern QC organization.

R&D Partners is seeking an Analytical Compliance Record Specialist to join a modern quality control organization within a leading biotechnology company in Switzerland. This role focuses on ensuring compliance with cGMP regulations and managing key quality processes, including deviations, changes, and CAPAs.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Manage compliance records for the department, including deviations, changes, and CAPAs.
• Facilitate and document root cause analyses.
• Collaborate with QA, scientists, and senior management for stakeholder management.
• 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 GMP standards are met.
• Document scientific and regulatory work in compliance with cGMP regulations.

Key Skills and Requirements:

• Education: Advanced degree (Bachelor’s, Master’s, or higher) in Chemistry, Pharmacy, Biology, or related natural sciences. Laboratory technicians with 10+ years of high-level GMP experience will also be considered.
• Experience: 3-5 years of professional experience in a regulated pharmaceutical or biotech environment.
• GMP Knowledge: Proven hands-on experience working under cGMP regulations is mandatory.
• QMS Proficiency: Experience with Veeva Vault or comparable Quality Management Systems (e.g., TrackWise).
• Compliance Expertise: Demonstrated ability to manage compliance records, including deviations, change control, and CAPAs.
• Language Skills: Business fluency in English (written and spoken) is mandatory; proficiency in German is highly beneficial.

About the Department:

The Analytical Development team focuses on developing resource-efficient analytical methods for drug manufacturing using advanced methodologies such as HPLC, GC, IC, and MS. The QC section ensures GMP-compliant analysis and release of materials, including raw materials, intermediates, APIs, and drug products, for clinical trials and commercial supply.

For more information, please contact Grant Van Schalkwyk.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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