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Process Excellence Specialist

Process Excellence Specialist

United BioSourceguadalajara, España
Hace 18 días
Descripción del trabajo

As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC, we provide services to enhance the entire drug development process and commercialization lifecycle - from clinical trial support to real-world evidence generation.

Embark on a rewarding career journey with UBC as a Process Excellence Specialist ! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values of Collaboration, Conscientiousness, Curiosity, Compassion, and Consultation. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

As a Process Excellence Specialist , you will manage Pharmacovigilance System Master Files for clients and support quality management system aspects.

Specific job duties :

  • Management of deviations and CAPAs.
  • Production of standardized quality metrics for the UBC Global PV Department and PV projects contracted by UBC clients.
  • Support PV Management in developing and maintaining UBC PV procedural documents and serve as the lead global PV trainer.
  • Involved in prioritization and dissemination of information related to global PV Safety Regulatory Intelligence.
  • Manage Pharmacovigilance System Master Files writing and updates for European clients, and support quality management system aspects.

Supervisory Responsibility : N / A

Skills and Qualifications :

  • Experience managing Pharmacovigilance System Master Files, including writing and updating.
  • Support experience for quality management systems.
  • Experience managing deviations and CAPAs.
  • Experience producing standardized quality metrics for the UBC Global PV Department and PV projects.
  • Experience supporting PV Management in procedural document development and maintenance.
  • Ability to prioritize and disseminate information related to global PV Safety Regulatory Intelligence.
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