Stericycle GxP Solutions are helping a client upgrade their existing ERP system and as a result, we require a CSV Consultant with experience in a regulated environment who can help to with ERP queries and also participate in compliance issues surrounding the software.
- Appropriate qualifications (Bachelor or Diploma ) in an IT or related discipline
- A strong background in an ERP system and technical understanding
- Project management experience
- Experience in systems requirements definition and selection of ERP’s
- Good organizational skills. Good verbal and written communication skills
- Experience in coordination contract staff, and/or experience in project management.
- Must have good interpersonal skills. Position will require a good deal of interdepartmental interaction and coordination.
- Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11 requirements.
- Must possess a thorough understanding of current industry guidance, including GAMP 5
- Must have ability to comprehend technical information related to computer software, computer and network hardware, and the associated regulatory requirements relating to them.
- Ability to present and defend validation data to a small group.
- Must have direct experience with computer validation and determining computer validation approach, including enterprise platforms systems as well as custom software projects.
The Ideal Candidate
Roles and Responsibilities
- Developing validation plans for specific computer system implementation projects.
- Knowledge of and exposure to application security and IT general controls
- Awareness of Governance, Risk and Compliance tools (including Identity Access • Management) in a FDA regulated industry
- Demonstrated experience in similar ERP project implementations
- Business process / requirements analysis skills
- Excellent teamwork, outstanding communication skills, both written and verbal
- Proven experience managing priorities and meeting tight deadlines.
If you would like to join our team of the top engineering and project management experts in the regulated industry, please submit your CV to email@example.com (indicating the job title in the subject line).
Alternatively, to apply for a job, you may post your CV to:
Stericycle GxP Solutions
About the Company
Stericycle GxP Workforce provide the best engineering experts in their field; experts who like the variety and challenges of working in new and innovative environments; who get the job done and have pride in their achievements.
Located in Cork, Ireland and with customers across global sites, we can offer our Engineers a great place to work with excellent working conditions. Our customers are responsible for some of the most significant medtech & pharmaceutical products of our time, so the projects that our people work on can directly affect patients and improve their quality of life.