Planet Pharma
CSV Consultant, e-Compliance / IT Governance, QA
Planet Pharma, Basking Ridge, New Jersey, us, 07920
Overview
CSV Consultant, e-Compliance / IT Governance, QA Join to apply for the CSV Consultant, e-Compliance / IT Governance, QA role at Planet Pharma. Responsibilities
Responsible for Computerized Systems Validation (CSV). Support complex technical quality requirements in CSV situations such as validation of new systems, upgrades, changes, or remediation. Provide guidance, interpretation, and assurance of CSV-related regulations, quality manuals, company policies, and procedures. Develop and manage GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols and Reports (IQ/OQ/PQ), User Acceptance Testing, Traceability Matrix, Validation Reports/Summary Reports, SOPs, Change Control Documentation, and Risk Assessment reports. Conduct system compliance risk assessment and Data Integrity risk assessment. Support and/or perform all aspects of CSV activities related to SDLC, including project planning, validation strategies, document development and reviews. Support enterprise CSV initiatives and remediation activities including 21 CFR Part 11 compliance. Experience with new technologies such as AI and ML and ability to lead AI/ML-based CSV activities. Lead or participate in vendor CSV audits as a subject matter expert (SME). Balance multiple demands to provide timely e-Compliance support to meet business objectives. Perform other related duties and assignments as required. Cross-functional and global team participation: collaborate with QA and functional units to ensure rigorous execution of computerized system validation QA and IT-related activities throughout the lifecycle, including initial implementation, change management, and decommissioning. Deeply understand and support method validation, process validation, equipment validation, and instrument QC/testing in manufacturing to ensure GMP compliance of production processes. Qualifications and Skills
Bachelor’s degree in a scientific or engineering discipline with 7+ years of experience in computer validation in Life Sciences/Healthcare. 7+ years’ experience in GxP/QA within FDA-regulated environments; GAMP 5 with risk-based CSV is required. Experience developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) across SDLC phases. Effective communication at all company levels; excellent technical writing; strong attention to detail; ability to manage time and prioritize; able to work independently. Familiarity with AI/ML in pharmaceutical contexts and ability to validate AI-enabled applications/systems. Ability to collaborate with audit teams, share observations, and lead remediation activities; promote information sharing of best practices to support high-quality trials and data. Education and Experience
7+ years in GxP/QA in FDA-regulated environments with risk-based CSV. Experience in developing validation documentation and testing protocols (IQ/OQ/PQ/UAT) across SDLC. Strong communication, collaboration, and time-management skills. Proficiency with Microsoft Word, Excel, PowerPoint, and Windows. The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Compliance Policies and Related Roles
Compliance Policies and Training Project Manager, Ethics and Business Integrity, North America (Morristown, NJ) Senior Manager, Global Compliance Transparency (Raritan, NJ) and other listed roles; location and salary ranges vary by posting.
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CSV Consultant, e-Compliance / IT Governance, QA Join to apply for the CSV Consultant, e-Compliance / IT Governance, QA role at Planet Pharma. Responsibilities
Responsible for Computerized Systems Validation (CSV). Support complex technical quality requirements in CSV situations such as validation of new systems, upgrades, changes, or remediation. Provide guidance, interpretation, and assurance of CSV-related regulations, quality manuals, company policies, and procedures. Develop and manage GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols and Reports (IQ/OQ/PQ), User Acceptance Testing, Traceability Matrix, Validation Reports/Summary Reports, SOPs, Change Control Documentation, and Risk Assessment reports. Conduct system compliance risk assessment and Data Integrity risk assessment. Support and/or perform all aspects of CSV activities related to SDLC, including project planning, validation strategies, document development and reviews. Support enterprise CSV initiatives and remediation activities including 21 CFR Part 11 compliance. Experience with new technologies such as AI and ML and ability to lead AI/ML-based CSV activities. Lead or participate in vendor CSV audits as a subject matter expert (SME). Balance multiple demands to provide timely e-Compliance support to meet business objectives. Perform other related duties and assignments as required. Cross-functional and global team participation: collaborate with QA and functional units to ensure rigorous execution of computerized system validation QA and IT-related activities throughout the lifecycle, including initial implementation, change management, and decommissioning. Deeply understand and support method validation, process validation, equipment validation, and instrument QC/testing in manufacturing to ensure GMP compliance of production processes. Qualifications and Skills
Bachelor’s degree in a scientific or engineering discipline with 7+ years of experience in computer validation in Life Sciences/Healthcare. 7+ years’ experience in GxP/QA within FDA-regulated environments; GAMP 5 with risk-based CSV is required. Experience developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) across SDLC phases. Effective communication at all company levels; excellent technical writing; strong attention to detail; ability to manage time and prioritize; able to work independently. Familiarity with AI/ML in pharmaceutical contexts and ability to validate AI-enabled applications/systems. Ability to collaborate with audit teams, share observations, and lead remediation activities; promote information sharing of best practices to support high-quality trials and data. Education and Experience
7+ years in GxP/QA in FDA-regulated environments with risk-based CSV. Experience in developing validation documentation and testing protocols (IQ/OQ/PQ/UAT) across SDLC. Strong communication, collaboration, and time-management skills. Proficiency with Microsoft Word, Excel, PowerPoint, and Windows. The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Compliance Policies and Related Roles
Compliance Policies and Training Project Manager, Ethics and Business Integrity, North America (Morristown, NJ) Senior Manager, Global Compliance Transparency (Raritan, NJ) and other listed roles; location and salary ranges vary by posting.
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