Yours Tasks

  • Review Batch Packaging Records as well as associated documents and approve intermediate products manufactured in the UK
  • Collate and preview documentation prior to approval by the Qualified Person
  • Support review and approval of new and updated records & documents for Quality Control & Assurance
  • Complete the Quality Approval of SOPs and write SOPs associated with Quality Assurance activities relating to product support
  • Participate in internal and external audits and support competent authority inspections
  • Raise & support investigations of customer complaints, incidents, deviations and associated corrective and preventive action
  • Complete the Quality Assurance Assessment of deviations and corrective and preventive action
  • Support Good Distribution Practices activities as well as the implementation of Change Control activities
  • Maintain current TSE files on each marketed product
  • Support for the Qualified Person

Your Profile

  • Ability to establish and maintain effective working relationships and communication links with internal and external stakeholders
  • Knowledge of QA, QS, GMP, GDP and basic understanding of pharmaceutical manufacturing and packaging
  • Good technical and scientific judgement paired with excellent networking and communication skills
  • Able to interpret complex data and present key findings
  • Basic understanding of GxPguidelines and regulations
  • Above average time management & organizational skills
  • Fluent in English and German

 

Application
Please submit your documents via e-mail to personal@eisai.net

Contact
Questions? Call us at +49-69-66585-0 – We look forward to helping you!

Our Head Office
Eisai GmbH, Edmund-Rumpler-Straße 3, 60549 Frankfurt/Main