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Validation Expert Consultant
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cGxPServe 4 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. 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 application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc. Accountable for authoring Validation Plan, and Validation Summary Reports and have fair understanding on other SDLC documents. Qualifications
10 to 12 years of Professional experience and strong knowledge 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 good executor with required communication. Knowledge of Pharmaceutical / Life Sciences as domain. Experience with MES, QMS (TrackWise), LIMS, Empower CDS, Chromatography data systems, Business Analytics, 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, ISA-95 high level understanding, OT security a plus, Standalone Systems Qualifications, Client/DCS Integrated with Manufacturing Equipment qualification. Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries
Research Services Referrals increase your chances of interviewing at cGxPServe by 2x Get notified about new Validation Consultant jobs in
Zionsville, IN .
#J-18808-Ljbffr
Validation Expert Consultant
role at
cGxPServe 4 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. 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 application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc. Accountable for authoring Validation Plan, and Validation Summary Reports and have fair understanding on other SDLC documents. Qualifications
10 to 12 years of Professional experience and strong knowledge 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 good executor with required communication. Knowledge of Pharmaceutical / Life Sciences as domain. Experience with MES, QMS (TrackWise), LIMS, Empower CDS, Chromatography data systems, Business Analytics, 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, ISA-95 high level understanding, OT security a plus, Standalone Systems Qualifications, Client/DCS Integrated with Manufacturing Equipment qualification. Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries
Research Services Referrals increase your chances of interviewing at cGxPServe by 2x Get notified about new Validation Consultant jobs in
Zionsville, IN .
#J-18808-Ljbffr