Katalyst CRO
Overview
Join to apply for the
Validation Engineer
role at
Katalyst CRO . Responsibilities
Plan, schedule, organize validation for new and existing applications from: Manufacturing Quality Control Clinical Draft, review & approve User Requirements (URS), Functional Specifications, Design Specs, Configuration Specs Prepare & review audit trails, risk assessments, GxP applicability Author Validation Plans & Summary Reports Perform traceability matrix creation Cross-department interaction; interact with stakeholders for cooperation and validation approvals Work closely with Quality and Compliance teams Participate in internal, vendor, and regulatory audits Regulatory alignment; ensure compliance with internal SOPs, forms, and Periodic Review procedures Conduct QMS and regulatory training Qualifications / Requirements
Software quality assurance or software validation Preferably within the medical device industry Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IEC 62304 Experience in non-product software validation Deep understanding of quality standards and regulatory requirements: FDA 21 CFR Part 820, ISO 13485, IEC 62304 Software quality assurance Software validation Non-product software tools (for testing, development, maintenance) Strong multitasking and prioritization Interpret and respond to regulatory & customer requirements quickly Work in teams and solve problems independently Seniorities
Mid-Senior level Employment type
Contract Job function
Industries Pharmaceutical Manufacturing
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Join to apply for the
Validation Engineer
role at
Katalyst CRO . Responsibilities
Plan, schedule, organize validation for new and existing applications from: Manufacturing Quality Control Clinical Draft, review & approve User Requirements (URS), Functional Specifications, Design Specs, Configuration Specs Prepare & review audit trails, risk assessments, GxP applicability Author Validation Plans & Summary Reports Perform traceability matrix creation Cross-department interaction; interact with stakeholders for cooperation and validation approvals Work closely with Quality and Compliance teams Participate in internal, vendor, and regulatory audits Regulatory alignment; ensure compliance with internal SOPs, forms, and Periodic Review procedures Conduct QMS and regulatory training Qualifications / Requirements
Software quality assurance or software validation Preferably within the medical device industry Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IEC 62304 Experience in non-product software validation Deep understanding of quality standards and regulatory requirements: FDA 21 CFR Part 820, ISO 13485, IEC 62304 Software quality assurance Software validation Non-product software tools (for testing, development, maintenance) Strong multitasking and prioritization Interpret and respond to regulatory & customer requirements quickly Work in teams and solve problems independently Seniorities
Mid-Senior level Employment type
Contract Job function
Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr