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Data Integrity Expert – Quality Assurance

Hessen, Deutschland

  • Gehalt: no
  • Auftragstyp: Fest
  • Eingestellt am: 18/12/2017

Tätigkeitsbeschreibung

Data Integrity Expert – Quality Assurance

 

Responsibilities:

 

  • Ensuring the integrity of production and laboratory data in accordance with regulatory requirements (FDA CFR Part 11 / EU GMP Annex 11)
  • Adjustment of internal regulations with the valid regulations
  • Maintenance of computerized systems (Periodic Reviews)
  • Conduct audit trail reviews
  • Planning and executing changes to improve data integrity
  • Support in selection and validation of new systems in production and laboratory
  • Setting up and monitoring the user administration of the systems
  • Preparation and execution of internal and external audits
  • Communication as the interface between production, QA, QC and IT
  • Training of employees and contact persons on data integrity

 

Your Profile

  • Completed degree in science or technology
  • Experience in GMP regulated environment
  • Knowledge of regulatory requirements for manufacture and testing of sterile medicines
  • Professional experience in the field of computer system validation and data integrity in the pharmaceutical industry
  • Fluent in German and good written and spoken English knowledge
  • High sense of responsibility and reliability
  • Good analytical and assessment skills
  • High communication and cooperation skills
  • Process and quality orientated as well as a strong affinity to automated processes

 

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