Responsibilities
1. Oversight and Compliance:
o IT CSV oversight for GXP computerized systems.
o Ensuring compliance with regulations (21 CFR Part 11, EU Annex 11, OECD 17, GAMP 5).
o Handling deviations, CAPAs, and change controls.
2. Documentation and Review:
o Creating and reviewing validation documentation, including user requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, traceability matrices, and validation summary reports.
3. Collaboration:
o Ability to work independently on validation projects but also collaborate with cross-functional teams (IT, QA, Operations).
o Strong communication, problem solving and leadership in CSV processes.
4. Issue Resolution and Communication:
o Identifying and resolving system issues.
o Communicating CSV requirements to senior management and stakeholders.
5. Audit and Regulatory Support:
o Supporting external audit programs for vendors.
o Interfacing with regulatory agencies.
6. Strategy and Improvement:
o Developing and implementing CSV strategies, policies, and procedures.
o Reviewing and approving validation documentation.
o Resource coordination, monitoring, and tracking of validation activities.
o Staying current with industry trends and regulatory changes.
o Continuous improvement of the CSV process.
o 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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