Computer Systems Validation Analyst
Computer Systems Validation Analyst PROFILE
Assist the Global IT Change Manager in defining the Global IT validation strategy and approach taking into account the relevant GxP requirements (e.g. EU Annex 11, FDA 21 CFR Part 11, Part 820, ISO 13485, etc.) and also other relevant regulatory requirements
- Develop and standardize appropriate procedures to be used in validating computerized systems:
- Develop, review and approve CSV policies, procedures, plans and protocols, and champion their adoption.
- Support project teams in defining the appropriate level of validation required based on a risk assessment
- Support project teams in the creation of the agreed validation pack of documents to support the validated state
- Support the business functions in the periodic review of systems to assess the current validated state
- Acts as a quality contact and primary Subject Matter Expert (SME) for Computer System Validation (CSV) and Risk Management
- Review proposed changes to validated computerized systems and identify the validation requirements necessary to maintain the system’s validation status after execution of the change.
- Support project teams in the assessment of proposed new computerized systems or software for GxP impact and where GxP impact is identified provide guidance on the risk based validation approach for the system, working with key stakeholders to achieve business goals.
- Support formal testing of computerized systems ensuring that test plans, test scripts and test results comply with the regulatory requirements based on system risk.
- Ensure that the IT Validation Master Plan is kept up to date and is aligned to corporate policies as they relate to computer systems validation
- Assists in all forms of audit and responds to audit observations and corrective actions as they pertain to computer systems validation
- Interacts professionally with company management, internal departments and other sites to effectively implement and maintain Quality Systems as they relate to CSV
- Identifies and implements improvement opportunities for established Quality Systems, processes, procedures, and training to support IT CSV activities
- Maintain up to date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer operations, and act as an information resource for the team and wider business.
- Such other activities as may be necessary from time to time
Overall objectives and responsibilities
This role is responsible for ensuring that Norgine IT Quality Management System, Validation documentation and all related processes, procedures and systems meet the requirements of all applicable regulations. This means not only working with other team members and consultants to identify any such weaknesses but also being instrumental in closing any such gaps identified. This may involve both directing others regarding what is needed and also making such changes themselves.Complexity
The job holder is accountable for the GxP assessment of changes to IT systems and advising project teams on the appropriate necessary and sufficient documentation required to support and manage that change based on riskAccountability
The individual will be accountable to the Global IT Change Manager for the execution of all duties.Relationships
- IT teams across Norgine
- Global Quality
- Business units impacted by required changes
Education and experience
- Bachelor’s degree preferred
- 5+ years’ experience in a validation and qualification of complex computer systems
- Thorough knowledge of cGMP regulations related to CSV
- Good written and oral communication skills
- Competent user of Microsoft Office
- Familiarity with multiple system types such as ERP and BI, LIMS, HRIS etc.
- Good understanding of business requirements, high-level solutions and infrastructure components, combined with CSV system experience.
- Wide experience of the various regulatory requirements relating to Eudralex Annexe 11, FDA CFR21 Part 11, etc..
- Experience of the data integrity implications of the regulated environment
- Confident communicator, able to network effectively in a diverse business community.
- Proactive, professional approach, undertakes tasks and responds to business requests in a positive and constructive manner.
- Keeps industry and organization knowledge current in order to provide up to date solutions and be best placed to advise on future capabilities.
- Able to balance the financial, quality, people and business needs aspects of solutions.
- Effective in understanding and anticipating business needs, able to manage expectations appropriately and meet business needs in line with organizational capabilities and standards.
- Effective, continuous team communication to promote open, honest information sharing and encourage input from team members on how to improve CSV approaches / team performance.