Futran Tech Solutions Pvt. Ltd.
Computer System Validation consultant
Futran Tech Solutions Pvt. Ltd., Seattle, Washington, us, 98127
Assurea is looking for CSV consultants for our pharmaceutical/ biotech client based in the greater Seattle area.. ***Travel to site is required.
Job Description and Qualification:
3 to 5+ years of Computer systems validation (CSV) experience in computerized equipment, QC lab and manufacturing systems is requiredAuthor, review and approve GxP computer system lifecycle documentation such as URS, FRS, CS/DS, risk assessments, validation plan, test protocol, summary reports and RTMDevelop and execute test protocols and test scripts (IQ/OQ/PQ) for computerized systemsKnowledge 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 integrityWrite and provide support for all CSV related deviations, discrepancies and change control documentationWork closely with project manager and CSV lead for validation activities and implementation timelinesEfficient 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
Job Description and Qualification:
3 to 5+ years of Computer systems validation (CSV) experience in computerized equipment, QC lab and manufacturing systems is requiredAuthor, review and approve GxP computer system lifecycle documentation such as URS, FRS, CS/DS, risk assessments, validation plan, test protocol, summary reports and RTMDevelop and execute test protocols and test scripts (IQ/OQ/PQ) for computerized systemsKnowledge 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 integrityWrite and provide support for all CSV related deviations, discrepancies and change control documentationWork closely with project manager and CSV lead for validation activities and implementation timelinesEfficient 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