Computer Systems Validation Analyst

Contract Type: Permanent

Salary / Benefits: Highly competitive Package

Job Elements: -

·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:

·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 formal testing of computerized systems ensuring that test plans, test scripts and test results comply with the regulatory requirements based on system risk.

·Assists in all forms of audit and responds to audit observations and corrective actions as they pertain to computer systems validation

The ideal candidate will have:

·Bachelor’s degree preferred

·5+ years’ experience in a validation and qualification of complex computer systems

·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

·Experience of the data integrity implications of the regulated environment

Petrie Recruitment Limited acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers.