Idorsia
Senior QA Compliance & Auditing Manager (GMP/GDP)(m/w/x)
Vollzeitnur vor OrtSenior
Allschwil
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BEBeOne Medicines I GmbH
Manager, Distribution & Regional Quality, Europe(m/w/x)
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Overseeing GMP/GDP operations and authorizing trade of finished pharmaceutical products. 5+ years distribution quality experience in pharma required. 4-day work week, company car for private use.
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Anforderungen
- 5+ years Distribution Quality experience in pharmaceutical industry
- Bachelors degree
- Solid QA foundation
- Understanding of product distribution quality requirements
- PC literacy
- MSOffice skills (Outlook, Word, Excel, PowerPoint)
- Veeva proficiency
- SAP proficiency
- Ability to work on computer extended periods
- EU GMP experience
- Very good interpersonal skills
- Very good listening skills
- Very good writing skills
- Very good negotiation skills
- Very good facilitation skills
- Very good attention to detail
Aufgaben
- Oversee GMP and GDP operations for commercial products
- Ensure compliance with EU GMP and GDP regulations
- Adhere to BeOne's internal quality processes
- Authorize trade of finished products from contract manufacturers
- Authorize trade of finished products from cooperation partners
- Authorize trade of BeOne-manufactured finished products
- Conduct batch review and EU QP batch certification
- Prepare batch release for commercial APIs and finished products
- Approve customers and wholesalers
- Manage deviations, including temperature excursions
- Handle CAPA and change control
- Manage distribution and market complaints
- Prepare and maintain quality documentation and reports
- Conduct GDP releases post QP batch certification
- Ensure inspection readiness in area of responsibility
- Support health authority inspections and audits
- Support new product launches in countries
- Represent quality in SAP projects for local affiliates
- Work with in-country wholesalers and distributors/3PLs
- Oversee GDP operations and compliance
- Implement quality requirements within distribution scope
- Support customer product returns and evaluation
- Establish and update quality agreements with 3PLs and distributors
- Prepare and provide key performance indicator metrics
Berufserfahrung
5 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Englisch – verhandlungssicher
Deutsch – Grundkenntnisse
Tools & Technologien
MSOfficeOutlookWordExcelPowerPointVeevaSAP
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne Medicines I 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 BeOne Medicines I GmbHÜber das Unternehmen
BE
PharmaceuticalsBasel
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