Bio DS Quality Standards Expert
Vor 2 Tagen
**Job Description**
OverviewAt Randstad (Switzerland) Ltd., we are seeking a highly skilled and experienced Bio DS Local Quality Specialist to join our team. This role is responsible for promoting high-quality standards, ensuring their integration into operations, and overseeing product documentation to ensure full product knowledge.
Responsibilities- Work closely with local and global teams to promote high-quality standards, integrating them into operations, and overseeing 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.
- Actively support site manufacturing and supply activities, particularly product changes, in compliance with GxP and UCB quality standards.
- 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.
- Proven ability to independently manage multiple tasks and coordinate complex projects while meeting critical deadlines.
This position offers a challenging and rewarding career opportunity with a competitive salary and excellent benefits package.
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