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Quality Assurance Specialist – Clinical Supply & QP Support(m/w/x)
Supporting QPs in certifying and releasing clinical trial materials, ensuring compliant documentation. Pharmaceutical QA/QC experience in a GMP environment required. Company pension scheme, outstanding career prospects.
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Anforderungen
- Vocational training as PTA, PKA, CTA, Pharmaceutical Assistant, or comparable qualification, or Bachelor's degree in Pharmacy, Life Sciences, or related discipline
- Quality Assurance or Quality Control in pharmaceutical industry
- Experience in GMP-regulated environment
- Previous exposure to documentation management, batch release, or clinical supply operations is an advantage
- Good understanding of GMP/GDP requirements and pharmaceutical quality systems
- Structured, detail-oriented, and quality-focused work approach
- Strong organizational and documentation skills
- Customer-oriented mindset with excellent communication skills
- Proficiency in Microsoft Office; experience with SharePoint, TrackWise or eDMS is beneficial
- Ability to work independently and collaboratively within cross-functional teams
- Fluent German and good English communication skills (written and spoken)
Aufgaben
- Support QPs in certification and release of clinical trial materials
- Ensure documentation is complete, compliant, and available for batch certification
- Prepare, review, and compile QP certification and batch release documentation
- Coordinate with customers, Global Project Managers, and internal teams for quality documentation
- Prepare Certificates of Release, Confirmations of Import, and QP Declarations
- Verify country-specific clinical trial approvals and maintain release documentation
- Support creation, review, and maintenance of SOPs and quality documents
- Maintain QP tracking tools, documentation records, and compliant archiving practices
- Support internal, client, and health authority audits
- Participate in investigations, CAPA activities, and quality system improvements
- Contribute to Permanent Process Improvement (PPI) initiatives
- Optimize QA processes
- Collaborate with cross-functional teams to ensure clinical trial supplies meet quality and regulatory standards
Berufserfahrung
Ausbildung
Sprachen
Tools & Technologien
Benefits
- Outstanding career and development prospects
- Company pension scheme
- Exciting company culture
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Fisher Clinical Services GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei Fisher Clinical Services GmbHÜber das Unternehmen
Das Unternehmen ist marktführend in den Bereichen Clinical Supply Chain Management Services und Clinical Supplies für Patienten weltweit.
fisherclinicalservices.comNejo bewertet ihn, und bringt ihn danach gemeinsam mit dir in Bestform.
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