Regulatory Compliance Specialist

vor 16 Stunden


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit
About Gi Group SA

Gi Group SA is a leading recruitment agency in the pharmaceutical industry, dedicated to providing top talent to our clients.

Job Title: Regulatory Compliance Specialist

We are seeking a highly skilled and experienced Regulatory Compliance Specialist to join our team in Basel. As a key member of our Quality Assurance department, you will be responsible for ensuring that our client's company meets all regulatory requirements.

Key Responsibilities:
  • Review and approve SOPs, protocols, reports, Certificate of Analysis, and other quality-related documents
  • Support investigations of deviations and out-of-specifications (OOS) issues
  • Maintain, record, and process corrective and preventive measures (CAPAs)
  • Act as a Quality Assurance point of contact for customers
  • Organize and manage customer audits and inspections
  • Apply and interpret audit and compliance requirements
  • Perform internal audits and provide support for GMP training
Requirements:
  • Master's degree in analytical chemistry, biochemistry, or life sciences
  • Fluency in English and German
  • At least 7 years of experience in the analytical-pharmaceutical environment, preferably in Quality Assurance
  • Profound expertise in the regulatory framework in the GMP environment, including ICH, FDA, USAP, and Ph. Eur.
  • Background in data integrity and computerized systems, risk assessment, and project support
  • Excellent problem-solving skills and outstanding communication skills
  • Prior experience as an auditor is an asset
Estimated Salary:

The estimated salary for this position is €80,000 - €110,000 per year, depending on experience.


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