Bio DS Local Quality Specialist (12 months)
Date de publication :
02 décembre 2024Taux d'activité :
100%- Lieu de travail :Bulle
Location: Bulle, Switzerland
Activity rate : 100%
Type of contract: Temporary contract (until 31.12.2025 with a possible extension)
Start Date: ASAP
The Bio DS Local Quality Specialist works closely with both local and global teams to promote high-quality standards and ensure their integration into operations. This role involves overseeing product documentation to ensure full product knowledge and implementing improvements in response to business needs, operational excellence, quality, or regulatory requirements. The Local Quality Specialist will also lead the Change Control Committee at the site level, ensuring smooth, fully integrated, prioritized, and coherent management of changes and regulatory impacts.
Major 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.
- Drive and develop the on-site quality culture, influencing teams to embed quality practices into daily activities. Provide support and expertise in quality systems to help business partners fulfill their quality responsibilities.
- Approve and authorize quality SOPs, Change Control, deviations, and related documents, while maintaining oversight of product-related documentation. Contribute to the efficient follow-up of product-related change controls by managing relationships with internal and external stakeholders, including CMOs.
- Review and approve validation protocols, CPV (Continuous Process Verification) reports, and Product Quality Reviews (PQRs). Contribute to investigations when necessary, ensuring effective follow-up of deviations, incidents, investigations, and CAPAs (Corrective and Preventive Actions).
- Actively contribute to simplifying and streamlining processes to remove obstacles and support continuous quality improvements. Participate in quality strategies for projects within your area of responsibility, providing support and expertise as needed.
- Approve protocols and reports for projects with regulatory impact.
- Perform Batch record review and Release / Reject activities as needed; actively contribute to the achivements of Team's objectives.
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qualifications
What will make you successful:
- 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. Note: this position does not involve batch release.
- 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.
- Ability to handle sensitive information with discretion and maintain confidentiality.
- Excellent communication skills (oral and written) in both French and English, with strong meeting preparation, presentation, and negotiation skills.
Laetitia Stirer
- Randstad UCB Bulle