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Analytical Compliance Record Specialist

Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world`s largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally. 

We are currently looking for an Analytical Compliance record Specialist for a 12-month contract based in Basel, Switzerland.

2 days a week home office possible

The Perfect Candidate holds a Master’s degree (or higher) in Organic Chemistry, Analytical Chemistry, or Pharmacy, possesses at least 3 years of professional experience in Quality Control, and has excellent GMP knowledge.

Main Responsibilitis:

  • Work in a modern quality control organization in compliance with cGMP regulations.
  • Management of Compliance Records for the department, mainly Deviations, Changes and CAPAs
  • Stakeholder management for the compliance record (including QA, Scientists, Senior Management)
  • Facilitation and Documentation of Root Cause Analyses
  • Active Participation in Quality Review Boards and other strategic and quality relevant governing bodies as needed
  • Inspection Support, including preparation and presentation of records to internal and external auditors / health authority inspectors
  • Critical evaluation of own work results
  • Key role in ensuring an appropriate GMP standard in the department
  • Scientific and regulatory documentation of the work done

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • Advanced Degree: A university degree (Bachelor’s, Master’s, or higher) in a relevant Natural Science field (e.g., Chemistry, Pharmacy, Biology)
  • Alternative Qualification: Candidates with a Laboratory Technician background will be considered if they possess over 10 years of high-level GMP experience
  • Between 3 to 5 years of professional experience within a regulated pharmaceutical or biotech environment
  • Proven, hands-on experience working under cGMP (current Good Manufacturing Practice) regulations is mandatory
  • QMS Software: Proficiency in Veeva Vault or a comparable Quality Management System (e.g., TrackWise)
  • Core Competencies: Demonstrated ability in managing compliance records, specifically Deviations, Change Control, and CAPAs
  • Business fluency in English is mandatory (written and spoken) for documentation and stakeholder management
  • Proficiency in German is considered a strong asset and highly beneficial for internal communication
  • Prior experience as a Deviation/CAPA Owner or previous experience in a Quality Assurance (QA) role is a nice to have

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.

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