Validation Project Lead
2 days ago
- Oversight and Compliance:
- Responsibility for IT CSV oversight in 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.
- 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.
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Validation Project Manager for Pharmaceuticals
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Validation Specialist Lead
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Senior Validation and Quality Assurance Lead
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Model Validation Lead
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Capital Project Validation Engineer
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Validation Lead Specialist
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Project Management Lead
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