Responsibilities
Oversight and Compliance :
IT CSV oversight for GXP computerized systems. Ensuring compliance with regulations (21 CFR Part 11, EU Annex 11, OECD 17, GAMP 5). Handling deviations, CAPAs, and change controls.
Documentation and Review :
Creating and reviewing validation documentation, including user requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, traceability matrices, and validation summary reports.
Collaboration :
Ability to work independently on validation projects but also collaborate with cross-functional teams (IT, QA, Operations). Strong communication, problem solving and leadership in CSV processes.
Issue Resolution and Communication :
Identifying and resolving system issues. Communicating CSV requirements to senior management and stakeholders.
Audit and Regulatory Support :
Supporting external audit programs for vendors. Interfacing with regulatory agencies.
Strategy and Improvement :
Developing and implementing CSV strategies, policies, and procedures. Reviewing and approving validation documentation. Resource coordination, monitoring, and tracking of validation activities. Staying current with industry trends and regulatory changes. Continuous improvement of the CSV process. Flexibility and adaptability in a changing regulatory environment.
Education, Experience & Skills Required Direct experience in leading, managing or participating in CSV projects in GxP environments. B.Sc. degree in Computer Science, Chemistry, or a relevant scientific field with substantial relevant progressive experience (greater than 3 years). Extensive experience in regulated industries with comprehensive working knowledge of GxP, 21 CFR Part 11, OECD 17, and EU Annex 11 compliance requirements. GLP /GCP /GMP experience is preferable. Experience in supporting regulatory inspections.
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IT CSV oversight for GXP computerized systems. Ensuring compliance with regulations (21 CFR Part 11, EU Annex 11, OECD 17, GAMP 5). Handling deviations, CAPAs, and change controls.
Documentation and Review :
Creating and reviewing validation documentation, including user requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, traceability matrices, and validation summary reports.
Collaboration :
Ability to work independently on validation projects but also collaborate with cross-functional teams (IT, QA, Operations). Strong communication, problem solving and leadership in CSV processes.
Issue Resolution and Communication :
Identifying and resolving system issues. Communicating CSV requirements to senior management and stakeholders.
Audit and Regulatory Support :
Supporting external audit programs for vendors. Interfacing with regulatory agencies.
Strategy and Improvement :
Developing and implementing CSV strategies, policies, and procedures. Reviewing and approving validation documentation. Resource coordination, monitoring, and tracking of validation activities. Staying current with industry trends and regulatory changes. Continuous improvement of the CSV process. Flexibility and adaptability in a changing regulatory environment.
Education, Experience & Skills Required Direct experience in leading, managing or participating in CSV projects in GxP environments. B.Sc. degree in Computer Science, Chemistry, or a relevant scientific field with substantial relevant progressive experience (greater than 3 years). Extensive experience in regulated industries with comprehensive working knowledge of GxP, 21 CFR Part 11, OECD 17, and EU Annex 11 compliance requirements. GLP /GCP /GMP experience is preferable. Experience in supporting regulatory inspections.
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