[Hiring] ERP Validation Consultant @Zifo
Apr 03, 2025 - Zifo is hiring a remote ERP Validation Consultant. 💸 Salary: unspecified. 📍Location: USA.
Role Description
The position is charged with supporting the implementation of an Enterprise Resource Planning (ERP) System, including:
- Support for system implementation activities
- System validation activities
- System hypercare activities
- Ensuring compliance with our client's policies and procedures
Support ERP system validation activities including:
- Validation planning
- Requirements gathering
- Design review
- Test planning and execution
- Validation reporting
Includes authoring responsibility for:
- Validation lifecycle documentation
- Discrepancy management
Apply risk-based methodology, including concepts of Computer Software Assurance (CSA) and critical thinking, to:
- Interpret and apply the strategy provided by validation leadership to the needs of the ERP system implementation
Support the development of operational phase needs for the ERP system, including:
- Change management
- User access review
- Audit trail review
- Business continuity
- Disaster recovery
Support risk assessment and data integrity assessment initiatives as a validation/compliance SME to ensure:
- The ERP system meets current industry expectations and company requirements
Follow-up on requests, issues, and projects, and report status to:
- Management
- Department leadership
- Working teams
Lead Data Integrity assessment for the ERP system.
Qualifications
- Bachelor’s degree or higher in relevant computer/technical/quality/scientific discipline, preferably multi-disciplinary with a strong technical and quality background
- Minimum of 4-6 years of experience supporting computer systems compliance activities in a high volume commercial / clinical pharma / healthcare facility
- Experience supporting the implementation of ERP Systems in the biopharmaceutical industry
- Understanding of industry standards and best practices for computer system compliance such as GAMP 5
- Knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10
- Knowledge of Regulatory Compliance and ICH Guidelines
- Practical experience with quality risk management and execution of risk-based approaches in support of computer system compliance activities
- Practical experience with use of concepts of Computer Software Assurance (CSA) and critical thinking
- Experience with automated testing tools preferred
Requirements
- Excellent written and verbal communications, including technical writing
- Self-motivated, able to produce high volume of work with limited supervision
- Organized, able to manage multiple assignments and work effectively under pressure
Benefits
- Competitive compensation package including accrued vacation
- Medical, dental, vision insurance
- 401k with company matching
- Life insurance
- Flexible spending accounts
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| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
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Salary
💸
unspecified
|
Remote
Location
USA
|
|
Job Type
unspecified
|
Posted
Apr 03, 2025
|
| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
