Aktuelle Jobs im Zusammenhang mit GCP Compliance Specialist - Basel, Basel-Stadt - TN Switzerland
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Regulatory Compliance Specialist
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GCP/PV/GLP Regulatory Affairs Specialist
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Regulatory Compliance Specialist
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Regulatory Compliance Specialist
vor 1 Tag
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GCP PV GLP Quality Assurance Specialist
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Compliance Specialist
vor 4 Stunden
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Quality Assurance Professional GCP/PV/GLP
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Regulatory Compliance Specialist
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Quality Assurance Manager GCP/PV/GLP
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Regulatory Compliance Specialist
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GMP Compliance Specialist
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Roche VollzeitRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
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Device Compliance Specialist
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GMP Compliance Specialist
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz F. Hoffmann-La Roche Gruppe VollzeitRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
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Pharmaceutical Quality Specialist
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Regulatory Compliance Officer
vor 4 Stunden
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Leiter des Compliance-Teams
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Basel, Basel-Stadt, Schweiz Helvetia Schweizerische Versicherungsgesellschaft AG TeilzeitJobbeschreibungWir suchen eine/n Senior Compliance Officer für unseren Konzern. Diese Rolle spielt eine entscheidende Funktion beim Schutz unserer Strategie und somit unser Image. Als erfahrener Experte möchten wir, dass Sie uns dabei helfen, unsere Business-Funktion zu stärken.Sie werden regelmäßig mit unserem Team zusammenarbeiten, um sicherzustellen,...
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Basel, Basel-Stadt, Schweiz Bayer CropScience Limited VollzeitJob OverviewThis is an exciting opportunity to join our Pharmaceuticals division as a Senior Regulatory CMC Specialist in Cell and Gene Therapy. You will play a key role in ensuring compliance with regulatory requirements and providing expertise to CGT companies.Duties and ResponsibilitiesProvide CMC and QA expertise to CGT companies, ensuring preparation of...
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Regulatory Compliance Specialist
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Basel, Basel-Stadt, Schweiz Syngenta VollzeitCompany OverviewSyngenta Crop Protection is a world market leader in crop protection, enabling farmers to counter threats and ensure safe, nutritious, affordable food for all.We help farmers overcome weeds, insects, and diseases as well as droughts and floods, heat and cold, from planting to harvesting. Our headquarters is based in Switzerland.Job...
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Regulatory Compliance Officer
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz ARTIDIS VollzeitRole OverviewThe Clinical Research Associate (CRA) plays a vital role in the success of our clinical studies. As a member of the Clinical Operations Team, this individual will be responsible for managing study sites globally, including site selection, initiation, monitoring, and close-out visits. They will also oversee data management activities, including...
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Compliance Expert
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz dSb Recruitment Consultancy Ltd. VollzeitCompany OverviewdSb Recruitment Consultancy Ltd. is an International General Merchandise Retailer entering the Swiss market in Spring 2025.We are seeking a skilled Regulatory Affairs Specialist to join our team in Basel.Job DescriptionThis exciting new role involves working closely with stakeholders at all levels to ensure the business complies with...
GCP Compliance Specialist
vor 1 Woche
We are seeking a highly skilled Quality Assurance Professional to join our team. As a Quality Assurance Professional, you will play a critical role in ensuring the integrity and success of clinical research.
- You will lead on-site or remote audits, evaluating compliance with GCP regulations, internal quality standards, and relevant guidelines.
- Prepare comprehensive audit reports outlining findings, observations, and recommendations for corrective actions.
- Ensure vendors adhere to internal quality standards, regulatory requirements, and contractual agreements.
GCP Compliance, Audits & Oversight:
- Develop and implement a robust audit strategy for vendors involved in clinical trials.
- Lead GCP audits of vendors, identifying gaps and implementing corrective and preventive actions (CAPAs).
- Ensure audit and inspection readiness across all vendor-related clinical trial activities.
- Serve as the GCP subject matter expert (SME) for vendor-related compliance matters.
Vendor Strategy & Oversight:
- Develop and implement a comprehensive GCP vendor management strategy.
- Lead the selection and qualification of vendors, including Contract Research Organizations (CROs), central laboratories, and data management providers.
- Establish and maintain strong vendor relationships to ensure successful collaboration.
Contracting & Compliance:
- Oversee contract negotiations, including Service Level Agreements (SLAs) and Key Performance Indicators (KPIs).
- Maintain thorough documentation related to vendor qualifications, contracts, and compliance reports.
Collaboration & Stakeholder Management:
- Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, and Procurement teams.
Risk Management & Continuous Improvement:
- Identify and mitigate risks associated with vendor partnerships and trial execution.
Qualifications & Requirements:
- Bachelor's degree in Life Sciences, Pharmacy, Business, or related field (Master's preferred).
- 8+ years of experience in vendor management, clinical operations, GCP auditing, or quality assurance within the pharmaceutical, biotechnology, or clinical research industry.
- Strong knowledge of GCP, ICH guidelines, and global regulatory requirements.
- Proven experience in GCP compliance, audit readiness, and vendor performance management.
- Experience with Veeva Vault for quality management, audit tracking, and vendor oversight.
- Excellent leadership, communication, analytical, and problem-solving skills.
- Ability to manage multiple projects and stakeholders in a fast-paced environment.
