- Winnipeg, Manitoba, Canada
- Associate
- 5–7 years
This role is responsible for supporting the validation effort and, where required leading projects to ensure that equipment, facilities, utilities, processes and computer systems utilized in the manufacture of product are validated for intended use.
Responsibilities
- Review, assess and approve (as applicable) CSV related materials for all local and global Computerized System projects
- Apply Global GxP requirements as part of a pragmatic validation strategy for computerized systems
- Establish and enhance the relationships between IT, validation, and business units, through collaboration, respectful challenge, and ability to strongly support QA decisions
- Continually monitor the effectiveness of the DI/CSV program, and recommend optimization opportunities as identified
- Participate, as needed, in audits of DI/computerized systems, both internal and external
Requirements
- BS Engineering/Chemistry/Microbiology or related field
- Nice to have: Aseptic/Sterile Manufacturing
- Nice to have: Qualification experience within the pharmaceutical or biopharmaceutical industries