1201 F. Hoffmann-La Roche AG
GMP Compliance Specialist(m/w/x)
Vollzeit
Berufserfahren
Keine Angabe
Basel
FI
Fisher Clinical Services GmbH28 Tage
Quality Assurance Specialist Pharma(m/w/x)
Vollzeit
Berufserfahren
Keine Angabe
79618 Rheinfelden (Baden), Marie-Curie-Str 16
Nejo KI-Zusammenfassung
As a Quality Assurance Specialist in the pharma sector, you will ensure compliance and quality in a regulated environment. Your role involves maintaining quality records, supporting audits, and driving continuous improvement initiatives to enhance patient safety.
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Anforderungen
- •Completed vocational training as PTA, MTA, CTA, or comparable qualification
- •Scientific background with relevant pharmaceutical experience
- •Experience in the pharmaceutical industry, preferably in GMP QA or QC
- •Experience within packaging and distribution environments
- •Solid GxP knowledge gained through training or practical experience
- •Experience in root cause analysis and investigation report writing
- •Strong understanding of EU GMP requirements
- •Proven ability to work in a structured, detail-oriented, and compliant manner
- •Proficiency in Microsoft Word, Excel, TrackWise, and electronic document management systems (eDMS)
- •Strong written and verbal communication skills and confidence working with cross-functional stakeholders
- •Excellent organisational and administrative skills
- •Fluency in German and English (B2 level or higher, written and spoken)
- •Strong team player with a proactive and quality-focused mindset
Abgeschlossene Berufsausbildung
Berufserfahrung
ca. 1 – 4 Jahre
Deine Aufgaben
- •Perform maintenance and quality review of TrackWise Quality Records
- •Approve Investigations, CAPAs, and Change Controls
- •Document deviations and quality events per GMP/GDP requirements
- •Support root cause analyses and conduct effectiveness checks for CAPAs
- •Manage scheduling and coordination for documentation reviews
- •Communicate effectively during documentation approvals
- •Provide QA input to support project timelines and production planning
- •Maintain accurate and audit-ready QA documentation
- •Oversee QC activities in Secondary Packaging, including Start-Up checks
- •Conduct In-Process Controls and Final Release checks
- •Coordinate with QC Team Leads on operational QC tasks
- •Ensure GMP/GDP compliance in secondary packaging processes
- •Support self-inspections, client audits, and regulatory inspections
- •Conduct QA Gemba walks
- •Review and update Standard Operating Procedures (SOPs)
- •Analyze and report quality metrics for continuous improvement
- •Identify and escalate quality risks, proposing mitigation actions
Tools & Technologien
Microsoft WordMicrosoft ExcelTrackWiseelectronic document management systems (eDMS)
Sprachen
Deutsch – verhandlungssicher
Englisch – verhandlungssicher
Deine Vorteile
Betriebliche Altersvorsorge
- •Company pension scheme
Karriere- und Weiterentwicklung
- •Outstanding career and development prospects
Lockere Unternehmenskultur
- •Exciting company culture
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. 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.
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