Katalyst CRO
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Computer System Validation Specialist
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Katalyst CRO 8 months ago Be among the first 25 applicants Join to apply for the
Computer System Validation Specialist
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Possess hands-on experience with the Veeva Vault QualityDocs System. Develop Computer System Validation (CSV) deliverables including Validation Plan, Validation Protocols (IQ, OQ, PQ), Validation Summary Report, Data Migration Plan and Trace Matrice. Conduct GxP Risk Assessments on computer applications utilized in regulated environments. Perform system assessments in compliance with 21 CFR Part 11 and Annex 11 regulations. Collaborate with Business Users, System Owners, IT teams, vendors, and Business Analysts to define validation requirements and plans. Provide oversight and training related to validation activities to multi-functional teams. Coordinate and support User Acceptance Testing (UAT) and Data Migration Activities. Review defects and collaborate with IT/Vendors for resolution, scheduling defect triage meetings as necessary. Act as the subject matter expert (SME) for CSV activities and maintain expertise in the CSV domain.
Responsibilities
Possess hands-on experience with the Veeva Vault QualityDocs System. Develop Computer System Validation (CSV) deliverables including Validation Plan, Validation Protocols (IQ, OQ, PQ), Validation Summary Report, Data Migration Plan and Trace Matrice. Conduct GxP Risk Assessments on computer applications utilized in regulated environments. Perform system assessments in compliance with 21 CFR Part 11 and Annex 11 regulations. Collaborate with Business Users, System Owners, IT teams, vendors, and Business Analysts to define validation requirements and plans. Provide oversight and training related to validation activities to multi-functional teams. Coordinate and support User Acceptance Testing (UAT) and Data Migration Activities. Review defects and collaborate with IT/Vendors for resolution, scheduling defect triage meetings as necessary. Act as the subject matter expert (SME) for CSV activities and maintain expertise in the CSV domain.
Requirements
Bachelor's or master's degree in engineering or a related field (equivalent education and work experience may be considered). 7+ years of experience in a Computer System Validation role within the pharmaceutical, biotech, or other regulated industries. Demonstrated experience in software quality assurance processes, Software Development Life Cycle (SDLC) methodologies, IT change management, documentation, verification, and validation techniques. Hands-on experience validating and maintaining the Veeva Vault QualityDocs system and data migration. Understanding of GAMP 5 techniques, software industry standards, and their implications on internal procedures and software quality. Working knowledge of FDA Quality System Regulation, 21 CFR Part 11 and Annex 11 regulations. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Job function
Information Technology Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for Computer Specialist roles.
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Computer System Validation Specialist
role at
Katalyst CRO 8 months ago Be among the first 25 applicants Join to apply for the
Computer System Validation Specialist
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Possess hands-on experience with the Veeva Vault QualityDocs System. Develop Computer System Validation (CSV) deliverables including Validation Plan, Validation Protocols (IQ, OQ, PQ), Validation Summary Report, Data Migration Plan and Trace Matrice. Conduct GxP Risk Assessments on computer applications utilized in regulated environments. Perform system assessments in compliance with 21 CFR Part 11 and Annex 11 regulations. Collaborate with Business Users, System Owners, IT teams, vendors, and Business Analysts to define validation requirements and plans. Provide oversight and training related to validation activities to multi-functional teams. Coordinate and support User Acceptance Testing (UAT) and Data Migration Activities. Review defects and collaborate with IT/Vendors for resolution, scheduling defect triage meetings as necessary. Act as the subject matter expert (SME) for CSV activities and maintain expertise in the CSV domain.
Responsibilities
Possess hands-on experience with the Veeva Vault QualityDocs System. Develop Computer System Validation (CSV) deliverables including Validation Plan, Validation Protocols (IQ, OQ, PQ), Validation Summary Report, Data Migration Plan and Trace Matrice. Conduct GxP Risk Assessments on computer applications utilized in regulated environments. Perform system assessments in compliance with 21 CFR Part 11 and Annex 11 regulations. Collaborate with Business Users, System Owners, IT teams, vendors, and Business Analysts to define validation requirements and plans. Provide oversight and training related to validation activities to multi-functional teams. Coordinate and support User Acceptance Testing (UAT) and Data Migration Activities. Review defects and collaborate with IT/Vendors for resolution, scheduling defect triage meetings as necessary. Act as the subject matter expert (SME) for CSV activities and maintain expertise in the CSV domain.
Requirements
Bachelor's or master's degree in engineering or a related field (equivalent education and work experience may be considered). 7+ years of experience in a Computer System Validation role within the pharmaceutical, biotech, or other regulated industries. Demonstrated experience in software quality assurance processes, Software Development Life Cycle (SDLC) methodologies, IT change management, documentation, verification, and validation techniques. Hands-on experience validating and maintaining the Veeva Vault QualityDocs system and data migration. Understanding of GAMP 5 techniques, software industry standards, and their implications on internal procedures and software quality. Working knowledge of FDA Quality System Regulation, 21 CFR Part 11 and Annex 11 regulations. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Job function
Information Technology Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for Computer Specialist roles.
Want to work with us, but don't see the right job listed?
New York, NY $128,000 - $160,000 1 week ago Don't see the right opportunity? Apply here!
New York, NY $176,000 - $250,000 1 week ago Want to work with us, but don't see the right job listed?
New York, NY $176,000.00 - $250,000.00 2 days ago Piscataway, NJ $90,000.00 - $135,000.00 3 months ago New York, NY $110,000.00 - $150,000.00 1 week ago New York, NY $220,000.00 - $260,000.00 1 week ago New York, NY $155,250.00 - $174,273.00 1 day ago New York, NY $150,000.00 - $283,000.00 2 weeks ago Brooklyn, NY $66,313.00 - $84,022.00 3 weeks ago Edison, NJ $110,000.00 - $115,000.00 1 month ago New York, NY $130,000.00 - $180,000.00 5 months ago Technology and Information Security Risk Specialist
New York, NY $160,000.00 - $190,000.00 1 day ago New York, NY $175,000.00 - $250,000.00 6 days ago New York, NY $120,000 - $180,000 4 months ago New York, NY $128,000 - $160,000 2 weeks ago New York, NY $100,500 - $173,250 1 week ago New York, NY $145,000 - $260,000 8 months ago New York, NY $100,000 - $170,000 1 week ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr