Local Quality Assurance Specialist
Vor 2 Tagen
**About the Role**
Job SummaryAs a Bio DS Local Quality Specialist, you will be responsible for promoting high-quality standards, ensuring their integration into operations, and overseeing product documentation to ensure full product knowledge. This role requires strong communication skills, attention to detail, and the ability to work effectively in a team environment.
Key Responsibilities- Work closely with local and global teams to promote high-quality standards, integrating them into operations.
- Oversee product documentation to ensure full product knowledge.
- Implement improvements in response to business needs, operational excellence, quality, or regulatory requirements.
- Lead the site Change Control Committee, ensuring smooth and coherent management of changes and regulatory impacts.
- Master's degree in Quality Management, Pharmaceutical Sciences, Biotechnologies, or related field.
- At least 4 years of experience in quality assurance, with a focus on project management related to the qualification and validation of manufacturing processes, and experience in batch record and validation protocol review.
- Experience in biotech is preferred, though a pharmaceutical background is also suitable.
- Strong understanding of GMP environment and demonstrated ability to write technical documents.
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