Regulatory Compliance Specialist
vor 16 Stunden
Gi Group SA is a leading recruitment agency in the pharmaceutical industry, dedicated to providing top talent to our clients.
Job Title: Regulatory Compliance SpecialistWe 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
- 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
The estimated salary for this position is €80,000 - €110,000 per year, depending on experience.
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