Development Quality Assurance Specialist
il y a 6 jours
Job Description
The Development Laboratory Quality Operational Partner is responsible for ensuring the establishment, implementation, maintenance, and continuous improvement of an effective Quality Management System (QMS) linked to product development.
This includes overseeing GMP activities in laboratories and production pilots, as well as non-GMP activities in development entities. The role requires driving continuous quality improvement processes, ensuring that the QMS supports product development and clinical supplies meet regulatory requirements and expectations.
Key Responsibilities
- Develop and implement quality management systems and procedures
- Ensure compliance with regulatory requirements and industry standards
- Conduct audits and inspections to identify areas for improvement
- Provide guidance and support to development scientists on quality-related matters
- Identify and mitigate compliance and quality risks
- Maintain accurate records and documentation
About You
- Bachelor's or Master's degree in a relevant field (e.g., Life Sciences, Engineering, or Quality Management)
- Minimum 3 years of experience in data integrity and documentation control within the biopharmaceutical industry
- Fluency in French and English
- Ability to work independently and handle complex situations
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