Job Description
Lead QA oversight for computer system validation (CSV) activities ensuring compliance with cGMP, GAMP 5, 21 CFR Part 11, and Annex 11 standards
Review user requirement specifications (URS) and risk assessments to ensure thorough validation planning and risk mitigation
Oversee installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities to verify system functionality and compliance
Ensure data integrity by applying ALCOA+ principles and managing change controls throughout validation and implementation processes
Act as the QA representative for system upgrades and new system implementations, collaborating closely with IT, Validation, and Engineering teams to drive project success
Apply strong CSV and QA project management skills to deliver compliant and efficient validation outcomes within a GMP environment, preferably in pharmaceutical or biologics sectors
Seniority level
Entry level
Employment type
Full-tim...
Review user requirement specifications (URS) and risk assessments to ensure thorough validation planning and risk mitigation
Oversee installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities to verify system functionality and compliance
Ensure data integrity by applying ALCOA+ principles and managing change controls throughout validation and implementation processes
Act as the QA representative for system upgrades and new system implementations, collaborating closely with IT, Validation, and Engineering teams to drive project success
Apply strong CSV and QA project management skills to deliver compliant and efficient validation outcomes within a GMP environment, preferably in pharmaceutical or biologics sectors
Seniority level
Entry level
Employment type
Full-tim...
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