Analytical Compliance Record Specialist

Analytical Compliance Record Specialist

Our client is a pioneer in Drug Discovery and Development and one of the front runners 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

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.

• 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

• 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., Track Wise)
• 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