GxP Compliance Specialist

vor 1 Woche

Wien, Wien, Österreich Takeda Vollzeit
About the Role

We are seeking a highly skilled and experienced professional to join our team as a Computerized Systems Specialist. In this role, you will be responsible for the implementation, maintenance, and validation of computerized systems in accordance with regulatory requirements.

Key Responsibilities
  • Implement and maintain computerized systems in compliance with 9 CFR pt 11, EU GMP Annex 11, and OECD advisory document No. 17 (and supplement)
  • Ensure all systems meet current GLP/GMP standards and guidelines for electronic records/signatures and data integrity
  • Lead the validation of computerized systems in collaboration with cross-functional teams
  • Develop user requirement specifications and SOPs
  • Provide training and support to end-users on system functionality and compliance requirements
  • Present at audits, particularly regarding maintenance activities, data integrity, and data security of computerized systems
  • Effective communication with stakeholders to ensure timely coordination
  • Continuously monitor best practices in the industry and regulatory changes related to computerized systems
  • Proactively develop improvement opportunities
  • Maintain a high standard of professionalism and integrity in all interactions
Requirements
  • Relevant degree (FH or Univ.) in a scientific field, with relevant experience
  • Experience in production in a GxP environment, preferably (Bio)Pharmaceuticals
  • Knowledge of GxP requirements for computerized systems
  • High sense of responsibility, reliability, and accuracy
  • High level of commitment and self-motivation, with a strong focus on quality, good communication skills, analytical and solution-oriented, social competence
  • Very good language skills: German, English
  • IT: Office, ERP (e.g. JDE), EQM (e.g. LIMS, Track Wise,...)

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