Computer System Validation Engineer Job at Katalyst Healthcares and Life Sciences, Jersey City, NJ

TUhRYjJhRlB5cmc1Y050NERUbWQvVDQ3aHc9PQ==
  • Katalyst Healthcares and Life Sciences
  • Jersey City, NJ

Job Description

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. Validation Summary Reports, traceability analysis. Defect Logging and Tracking till closure. Develop, approve, and execute validation deliverables for computerized systems, including validation plans, risk assessments, and traceability matrices. Author and update documentation to support ongoing CSV compliance. Prepare or review all levels of validation documents including Validation (Strategy) Plans, User Requirement Specifications. Definition Documents, including Functional Specifications S/W Design Specifications or Configuration Documents and SOPs. Qualification Documents and Test Specifications (IQ, OQ, PQ) Traceability Matrices, Risk Analysis. Validation Reports, Change Controls/ Events / Deviations etc. Assess the impact of changes proposed to computerized systems and the level of change required. Provide validation strategy to the introduction of computerized systems. Collaborate with the key stakeholders (Information Systems, Software assurance, business users and suppliers etc.) and management on all related matters on a regular basis. Katalyst Healthcares and Life Sciences

Job Tags

Similar Jobs

Varada Consulting

Site Reliability Engineer (SRE) -TS/SCI Job at Varada Consulting

Join to apply for the Site Reliability Engineer (SRE) -TS/SCI role at Varada Consulting3 months ago Be among the first 25 applicantsJoin to apply for the Site Reliability Engineer (SRE) -TS/SCI role at Varada ConsultingSite Reliability EngineerJob Location: Washington... 

Technology Security Associates, Inc.

Junior Foreign Disclosure Analyst Job at Technology Security Associates, Inc.

 ...Job Description Job Description Overview: Technology Security Associates (TSA) is currently seeking a Junior Foreign Disclosure Representative to support the Foreign Disclosure Officer at a dynamic NAVAIR Program Office. This position will require on-site/in-person... 

GardaWorld Corporation

Security Officer - Patrol Driver Job at GardaWorld Corporation

 ...GardaWorld Security Services is Now Hiring a Response Security Officer! Ready to suit up as a Response Security Guard? What matters most...  .... Tell us about how you embrace change a Security Officer, Patrol, Officer, Driver, Security, Security Guard GardaWorld Corporation

CommonSpirit Health

Family Medicine, Family Medicine Physician Job at CommonSpirit Health

 ...exceptional care to the Woodland residents and surrounding areas for over 100 years. We are in need of additional, outpatient Family Medicine physicians who would pratice in our Davis location. New and experienced physicians are encouraged to apply. Bilingual is a plus... 

Infoshare Systems, Inc.

Quote to Service Q2S BA Job at Infoshare Systems, Inc.

 ...Experience with business process analysis and documentation Proficiency in using Salesforce customer relationship management (CRM) system and SAP enterprise resource planning (ERP) system Experience with Sales processes, including Account management, lead management...