Katalyst CRO
IT CSV & CQV Validation Lead – Katalyst CRO
Responsibilities
Develop and author comprehensive validation and quality documentation, including protocols, reports, risk assessments, SOPs, and other project-related materials.
Ensure all documentation complies with regulatory standards such as FDA, EMA, GxP, and other relevant guidelines.
Review and approve validation documents to confirm alignment with project objectives and regulatory requirements.
Lead and oversee multiple quality and validation projects, clearly communicating goals, timelines, and key milestones.
Proactively identify potential risks and implement mitigation strategies to ensure timely and successful project delivery.
Collaborate with internal teams and external stakeholders to ensure alignment on deliverables and expectations.
Conduct regular project status meetings and prepare progress reports for stakeholders.
Ensure all validation activities and documentation adhere to industry best practices and regulatory requirements.
Provide support during internal and external audits by offering expertise in validation and quality assurance.
Serve as a subject matter expert in quality systems, validation methodologies, and regulatory compliance.
Requirements
IT CSV Validation of IT systems.
CQV Qualification of Equipment.
Knowledge of regulatory frameworks (e.g., FDA 21 CFR Parts 11, 211, 820; industry standards such as ISPE, GAMP 5).
Experience with Veeva Quality Docs, ServiceNow, JIRA, and Kneat.
Pharma industry experience is mandatory.
Experience in authoring validation documents and managing validation projects.
Demonstrated ability to lead and oversee multiple quality and validation projects.
Seniority Level
Associate
Employment Type
Contract
Job Function
Information Technology
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Develop and author comprehensive validation and quality documentation, including protocols, reports, risk assessments, SOPs, and other project-related materials.
Ensure all documentation complies with regulatory standards such as FDA, EMA, GxP, and other relevant guidelines.
Review and approve validation documents to confirm alignment with project objectives and regulatory requirements.
Lead and oversee multiple quality and validation projects, clearly communicating goals, timelines, and key milestones.
Proactively identify potential risks and implement mitigation strategies to ensure timely and successful project delivery.
Collaborate with internal teams and external stakeholders to ensure alignment on deliverables and expectations.
Conduct regular project status meetings and prepare progress reports for stakeholders.
Ensure all validation activities and documentation adhere to industry best practices and regulatory requirements.
Provide support during internal and external audits by offering expertise in validation and quality assurance.
Serve as a subject matter expert in quality systems, validation methodologies, and regulatory compliance.
Requirements
IT CSV Validation of IT systems.
CQV Qualification of Equipment.
Knowledge of regulatory frameworks (e.g., FDA 21 CFR Parts 11, 211, 820; industry standards such as ISPE, GAMP 5).
Experience with Veeva Quality Docs, ServiceNow, JIRA, and Kneat.
Pharma industry experience is mandatory.
Experience in authoring validation documents and managing validation projects.
Demonstrated ability to lead and oversee multiple quality and validation projects.
Seniority Level
Associate
Employment Type
Contract
Job Function
Information Technology
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr