Bio DS Local Quality Specialist

vor 12 Stunden


Bulle FR, Freiburg, Schweiz Randstad Vollzeit
Job Overview
Randstad is seeking a skilled Bio DS Local Quality Specialist to join our team in Switzerland. As a key member of our quality assurance department, you will be responsible for promoting high-quality standards and ensuring their integration into operations.

The ideal candidate will have a strong understanding of GMP environments and the ability to write technical documents. They will also possess excellent communication skills in both French and English, with the ability to prepare meeting materials, present reports, and negotiate with stakeholders.

This is an exciting opportunity to work with a dynamic team and contribute to the development of quality systems that support business growth and operational excellence.

Key Responsibilities:
* Collaborate with local and global teams to promote high-quality standards and ensure their integration into operations.
* Oversee product documentation to ensure full product knowledge and 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.

What You'll Need:
* 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.
* 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.
* Excellent communication skills (oral and written) in both French and English, with strong meeting preparation, presentation, and negotiation skills.

Our Ideal Candidate Will Have:
* A strong background in quality assurance and project management.
* Excellent communication and interpersonal skills.
* The ability to work effectively in a fast-paced environment and prioritize multiple tasks and projects.

We Offer:
* Competitive compensation and benefits package.
* Opportunities for career growth and professional development.
* A dynamic and supportive work environment.


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