Katalyst CRO
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Validation Expert Consultant
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Katalyst CRO . Responsibilities
Well versed with Manufacturing, Quality and engineering system and their validations. OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus), Client/DCS Integrated with Manufacturing Equipment qualification. Provide an application validation expertise practically on different scenarios as applicable case to case (e.g., standalone/enterprise). Accountable for authoring Validation Plan and Validation Summary Reports with a fair understanding of other SDLC documents. Client/DCS Qualification and standalone systems qualifications. Requirements
10 to 12 years of professional experience with real-time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Well versed with Manufacturing, Quality and engineering system and their validations. Stakeholder management and strong communication skills. Knowledge of Pharmaceutical / Life Sciences domain. Experience with MES, QMS (TrackWise), Lab solutions (e.g., LIMS, Empower), Chrome LEON, Business Analytics, and middleware. Hands-on experience with testing tools like Client ALM, Kneat, and SNOW. IT QMS, Validation/Qualification, Risk management, Handling of defects/Deviations, Investigations, CAPA Handling, Test Management & Compliance. Understanding of latest regulations (e.g., 21 CFR Part 11, EU Annex 11) and guidelines (e.g., GAMP5). OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus). Client/DCS Qualification and integration with manufacturing equipment. ISA-95 high level understanding. OT Security experience is a plus. Standalone Systems Qualifications. Seniority level
Mid-Senior level Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing
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Validation Expert Consultant
role at
Katalyst CRO . Responsibilities
Well versed with Manufacturing, Quality and engineering system and their validations. OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus), Client/DCS Integrated with Manufacturing Equipment qualification. Provide an application validation expertise practically on different scenarios as applicable case to case (e.g., standalone/enterprise). Accountable for authoring Validation Plan and Validation Summary Reports with a fair understanding of other SDLC documents. Client/DCS Qualification and standalone systems qualifications. Requirements
10 to 12 years of professional experience with real-time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Well versed with Manufacturing, Quality and engineering system and their validations. Stakeholder management and strong communication skills. Knowledge of Pharmaceutical / Life Sciences domain. Experience with MES, QMS (TrackWise), Lab solutions (e.g., LIMS, Empower), Chrome LEON, Business Analytics, and middleware. Hands-on experience with testing tools like Client ALM, Kneat, and SNOW. IT QMS, Validation/Qualification, Risk management, Handling of defects/Deviations, Investigations, CAPA Handling, Test Management & Compliance. Understanding of latest regulations (e.g., 21 CFR Part 11, EU Annex 11) and guidelines (e.g., GAMP5). OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus). Client/DCS Qualification and integration with manufacturing equipment. ISA-95 high level understanding. OT Security experience is a plus. Standalone Systems Qualifications. Seniority level
Mid-Senior level Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr