Regulatory Compliance Specialist
Vor 2 Tagen
- Compliance Management: Ensure adherence to GMP & GDP regulations, quality technical agreements, and Sobi's procedures and policies.
- Supplier Qualifications: Oversee supplier qualification, validation, and performance monitoring.
- Quality Risk Assessments: Implement and maintain quality risk assessments and KPIs to identify and mitigate potential quality risks.
- Communication: Serve as the primary contact for all quality-related activities with external suppliers, internal stakeholders, and regulatory authorities.
Required Skills and Qualifications
- Bachelor's degree in pharmacy, medicine, veterinary medicine, chemistry, technology, or natural science.
- More than 10 years of experience in pharmaceutical or biotech industry, preferably with a background in quality assurance or regulatory affairs.
- Strong understanding of GMP & GDP regulations, quality management systems, and regulatory requirements.
- Excellent communication, interpersonal, and leadership skills.
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