Bio DS Quality Standards Expert

Vor 2 Tagen


Bulle FR, Freiburg, Schweiz Randstad (Switzerland) Ltd. Vollzeit

**Job Description**

Overview

At 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
  1. 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.
  2. Implement improvements in response to business needs, operational excellence, quality, or regulatory requirements.
  3. Lead the site Change Control Committee, ensuring smooth and coherent management of changes and regulatory impacts.
  4. Actively support site manufacturing and supply activities, particularly product changes, in compliance with GxP and UCB quality standards.
Required Skills and Qualifications
  • 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.
Benefits

This position offers a challenging and rewarding career opportunity with a competitive salary and excellent benefits package.



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