35
350 Lilly Deutschland GmbH
1 Monat

Senior Quality Associate, Parenteral(m/w/x)

Vollzeit
Senior
Keine Angabe
Alzey

In this role, you will oversee quality assurance processes, mentor team members, and ensure compliance with GMP standards. Daily activities will involve guiding investigations, supporting inspections, and driving continuous improvement initiatives.

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Anforderungen

  • Bachelor's degree in science, engineering, or pharmaceutical-related field or equivalent experience
  • Minimum 5 years in the pharmaceutical industry with Quality Assurance experience
  • Understanding of cGMP regulations and practices
  • Fluency in English and German
  • On-site presence required
  • Experience in parenteral manufacturing environments
  • Experience with C&Q and Validation oversight
  • Knowledge of US, EU, Japan and other pharmaceutical manufacturing regulations
  • Proficiency with applicable computer systems
  • Strong oral and written communication skills
  • Interpersonal skills and teamwork ability
  • Root cause analysis and troubleshooting skills
  • Attention to detail and quality systems maintenance
  • Ability to work independently or as part of a team
  • Technical writing and communication skills
  • Computer System Quality Assurance (CSQA) experience
  • Experience with Manufacturing Execution Systems
  • Use of KNEAT or other electronic validation software
Bachelor-Abschluss

Berufserfahrung

5 Jahre

Deine Aufgaben

  • Provide daily oversight and guidance to the process team
  • Advise on non-conformance investigations and change controls
  • Support procedures, validations, and batch disposition
  • Assist with commissioning and qualification activities
  • Mentor and coach operations personnel on quality matters
  • Monitor GMP programs and quality systems in operational areas
  • Serve as the Quality point of contact for the local process team
  • Assess and triage deviations within the local process team
  • Collaborate with support groups and external partners on product issues
  • Participate in self-led inspections and support regulatory inspections
  • Initiate, review, and approve quality-related documents
  • Engage in continuous improvement projects to enhance productivity
  • Approve commissioning and validation documents for compliance
  • Network with Global Parenteral Network sites to share best practices

Tools & Technologien

KNEATManufacturing Execution SystemsComputer System Quality Assurance

Sprachen

Englischverhandlungssicher

Deutschverhandlungssicher

Deine Vorteile

Betriebliche Altersvorsorge

  • Excellent company pension plan

Sonstige Vorteile

  • Individual benefits

Karriere- und Weiterentwicklung

  • Career development opportunities

Weiterbildungsangebote

  • Access to professional development
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 350 Lilly Deutschland 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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