2023-08-23 14:48:55

QUALITY ASSURANCE MANAGER (GMP)

Job Description

- Develop, implement, and maintain a Quality Management System (QMS)
- Create and document key quality procedures
- Review and approve procedures
- Manage quality-related documentation
- Ensure GMP compliance
- Review and approve qualification protocols
- Implement and manage environmental monitoring
- Manage quality processes
- Conduct self-inspections
- Prepare for regulatory inspections

Requirements

- Master’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field; advanced degree preferred
- Previous experience in quality assurance within the medical sector, pharmaceutical or biotechnology industry
- Strong knowledge of cell biology, cell culture and analytical techniques for immune cell analysis on the cellular and molecular level
- Knowledge of GMP regulations and international standards (EMA, FDA) related to drug manufacturing preferred
- Proven experience in establishing and implementing pharmaceutical quality systems
- Strong problem-solving, communication and interpersonal skills with the ability to work collaboratively in a fast-paced, dynamic environment. Attention to detail
- Being a self-starter and a team player
- Fluency in written and oral English and Estonian

Company offers

- Full time permanent employment contract in a leading, rapidly developing international biotech company
- An opportunity to make an impact in drug development
- Inspiring colleagues and supportive environment for professional development
- Team-building events and activities
- Company benefits package and team events
- Work location in Tartu, Estonia

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