Pharmaceutical, Biotechnology, Life SciencesIndustries
Requirements
Excellent educational background (minimum BSc) in Pharmaceuticals, Biotechnology, Chemistry Engineering or Computer Science
2+ years of experience in the pharmaceutical, biotechnology, or other regulated industries, with special emphasis on the manufacturing processes
Understanding of GxP, FDA, and other global regulatory requirements for EBRs
Excellent communication and interpersonal skills
Ability to work as part of a team
Availability to travel for visiting clients is required
Proficiency in spoken and written English
(Nice-to-have) 1+ years of experience in the implementation or validation of EBRs
(Nice-to-have) Previous experience in Computer Systems Validation and/or Pharma Validation departments
(Nice-to-have) Experience, as a user, of other systems including Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS)
Responsibilities
Provide consulting services to clients on the implementation and best use of Aizon’s EBR software solution (Execute)
Being part of the projects and Proofs of Value, as assigned by the company, and keeping in touch with clients
Deliver training on Execute to clients
Follow and fulfill Aizon Compliance team directions to ensure adherence to GxP regulations in the delivery of the consultancy tasks
Support Aizon Compliance teams, when needed, in the preparation of the project documentation, testing evidence, validation requirements, etc
Work collaboratively with solution architects/data engineers, quality engineers, usability experts, support engineers, and clients to improve the Execute software solution and its associated implementation services
Collaborate with the EBR Consulting Team Leader in the definition of best practices and learnings which will help to optimize and improve the delivery of future projects