IT Validation Specialist

hace 15 horas

Rubí, Barcelona, España B. Braun Group A tiempo completo

Coordinate qualification and validation activities between IT and Business teams, ensuring quality in IT systems and processes within regulated environQments. Drive the transition to paperless validation systems and ensure documentation complies with global company standards and regulatory requirements. The role also involves executing and documenting system validations following GAMP methodology and Agile processes, supporting global implementations of new systems, and managing Change Controls. Additionally, contribute to innovation by applying AI tools to GxP systems, administer validation documentation across company platforms, deliver CSV training sessions, and oversee periodic reviews to maintain system compliance.

Duties And Responsibilities

  • Coordinate qualification and validation activities between IT and business, including the adaptation to paperless validation systems.
  • Execution and documentation of qualification and validation activities according to GAMP, V-Model and Agile Development methodologies.
  • Revision and optimization of the department documentation to keep it easy to use and up to date on regulation, directives and global procedures and policies.
  • Contribution and participation with global teams for local and global rollouts or new systems implementation.
  • Main point of contact among Global and Local IT teams and the local Quality Departments.
  • Manage and approve Change Control processes, including documentation, to maintain the qualified status of applications and infrastructure.
  • Support the department with the use of IA tools applied to GxP systems.
  • Support to the administration of the Validation documentation in the different platforms.
  • Execute trainings for CSV (Computer System Validation).
  • Initiate and monitor periodic reviews.

Professional Competencies

  • Bachelor's degree in Computer Science, Engineering or related field, or another educational degree/certificate with experience in the pharmaceutical sector.
  • Knowledge of GxP requirements and standards, i.e., ICH guides, ISO 9001, ISO 13485, 21 CFR 820.
  • Excellent CSV and GAMP 5 knowledge.
  • Experience with agile development according to SCRUM, KanBan.
  • Knowing requirement management tools, i.e. JIRA, Polarion.
  • SAP QM knowledge would be beneficial.
  • In-depth knowledge of MS Office products, especially Word, Excel and PowerPoint.
  • Experience with cloud platforms and technologies.
  • Good verbal and written communication skills in English (C1).
  • Availability to travel occasionally.

Personal Competencies

  • Technically enthusiastic and willing to learn attitude is required.
  • Critical thinking.
  • Ability to work unsupervised in a multi-task environment in a global team.
  • Very good analytical and conceptual skills.
  • Good communication skills.
  • Pure enthusiasm to bring forward team's capabilities and B. Braun.
  • Experience in managing internal and external project members.
  • High level of self-initiative.

B. Braun Medical, S.A. U. | Aitana Altuna

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