TechnoGen
Computer System Validation Lead / CSV Lead
TechnoGen, San Mateo, California, United States, 94409
Computer System Validation Lead / CSV LeadREMOTE / Work From Home** rate : Market / Flexible
We are looking for a CSV Lead with GMP experience in creation, review and approval of CSV deliverables for laboratory informatics implementation projects.
Responsibilities:Improve the effectiveness and efficiency of the existing CSV delivery model through the creation of various templates, stools, training courses, and the periodic collection of KPI metricsProvide thought leadership for GMP Systems by working across different departments to deliver CSV-related programs, innovations, and communicationsContribute to the operational and process improvement initiatives related to Quality and ComplianceApply CSV expertise to make a major contribution to a specific business unit or departmentInterpret and execute company policies and procedures that typically and recommend modifications to operating policiesDevelop Validation testing strategy in accordance with Gilead's policy and proceduresWork closely with other validation team members to ensure system impact is assessed and mitigation strategy is in place for multiple sitesPartner closely with the business to ensure that CSV methodologies are well understood and applied in a manner that will procedure the most value on LIMS projectsLearn, become proficient the EDMS (Electronic Data Management System), for document review, approval and ELMS (Electronic Leaning Management System) for documenting and performing assigned trainingPrepare, revise and obtain approval of the following documents for GMP laboratories related to the LIS systems:
Standard Operating Procedures (SOPs)Work Instructions (WIs)FormsUser Manuals / User Guides / User References / Quick Reference Guides and Training MaterialTraining PlansReference DocumentsSpecificationsReports
Experience / Skills:
Minimum of 10+ years of experience working in CSV field and GMP Pharmaceutical / Biotechnology / Medical Device environmentAdvanced knowledge and expertise Computer System Validation, FDA, international requirements and Part 11 requirementsComputer Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is requiredAbility to master technical content through interaction with subject matter expertsLaboratory experience as a chemist or microbiologist, et al is preferredUnderstanding of programming and relational database concepts is requiredBA/BS degree; e.g. Biology, Chemistry, Computer Science and/or Technology disciplines is preferred
Thanks & Regards
Mateenuddin| 571-934-3415
We are looking for a CSV Lead with GMP experience in creation, review and approval of CSV deliverables for laboratory informatics implementation projects.
Responsibilities:Improve the effectiveness and efficiency of the existing CSV delivery model through the creation of various templates, stools, training courses, and the periodic collection of KPI metricsProvide thought leadership for GMP Systems by working across different departments to deliver CSV-related programs, innovations, and communicationsContribute to the operational and process improvement initiatives related to Quality and ComplianceApply CSV expertise to make a major contribution to a specific business unit or departmentInterpret and execute company policies and procedures that typically and recommend modifications to operating policiesDevelop Validation testing strategy in accordance with Gilead's policy and proceduresWork closely with other validation team members to ensure system impact is assessed and mitigation strategy is in place for multiple sitesPartner closely with the business to ensure that CSV methodologies are well understood and applied in a manner that will procedure the most value on LIMS projectsLearn, become proficient the EDMS (Electronic Data Management System), for document review, approval and ELMS (Electronic Leaning Management System) for documenting and performing assigned trainingPrepare, revise and obtain approval of the following documents for GMP laboratories related to the LIS systems:
Standard Operating Procedures (SOPs)Work Instructions (WIs)FormsUser Manuals / User Guides / User References / Quick Reference Guides and Training MaterialTraining PlansReference DocumentsSpecificationsReports
Experience / Skills:
Minimum of 10+ years of experience working in CSV field and GMP Pharmaceutical / Biotechnology / Medical Device environmentAdvanced knowledge and expertise Computer System Validation, FDA, international requirements and Part 11 requirementsComputer Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is requiredAbility to master technical content through interaction with subject matter expertsLaboratory experience as a chemist or microbiologist, et al is preferredUnderstanding of programming and relational database concepts is requiredBA/BS degree; e.g. Biology, Chemistry, Computer Science and/or Technology disciplines is preferred
Thanks & Regards
Mateenuddin| 571-934-3415