Job Description and Qualification:

• 3 to 5 years of Computer systems validation (CSV) experience in computerized equipment, QC lab and manufacturing systems is required
• Author, review and approve GxP computer system lifecycle documentation such as URS, FRS, CS/DS, risk assessments, validation plan, test protocol, summary reports and RTM
• Develop and execute test protocols and test scripts (IQ/OQ/PQ) for computerized systems
• Knowledge of regulatory requirements and standard best practices, (e.g. GLP/GMP, 21 CFR Part 11, Annex 11, GAMP5) with respect to computerized systems and data integrity
• Write and provide support for all CSV related deviations, discrepancies and change control documentation
• Work closely with project manager and CSV lead for validation activities and implementation timelines
• Efficient and skilled in writing documents / formatting / understanding Microsoft office and able to create templates etc.
• Have the ability to work with multiple clients and projects