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15 hours ago
Company Overview: At Antaros Medical AB, we combine cutting-edge imaging with extensive experience in drug development and deep knowledge of disease mechanisms. Our focus is on cardiorenal & metabolic disease, with a global network of collaboration partners and customers.
About the Role: We are seeking a highly skilled Lead Quality Assurance Specialist to join our team. In this role, you will be responsible for managing QA activities within our organization, ensuring compliance with regulations and guidelines.
Main Responsibilities:
- Manage and maintain our quality system in collaboration with functional leads and QA colleagues
- Support the development of new processes and quality system documents
- Conduct internal audits and vendor audits as per our risk-based audit plan
- Host and manage inspections, sponsor audits, and vendor assessments
- Provide day-to-day general QA support
Requirements:
- University degree in Natural Science or Medicine
- Several years of experience in the pharmaceutical industry, CROs, or similar business, including several years of experience in a QA position
- Extensive understanding of and experience in ICH-GCP
- Broad understanding of the full drug development process
- Excellent knowledge of spoken and written English
Benefits:
- Opportunity to make a difference in the field of medical research
- Chance to develop your skills and contribute to the growth of our organization
- Collaborative and dynamic work environment
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