Responsibilities
1. 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.
1. 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.
1. 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.
1. Issue Resolution and Communication:
* Identifying and resolving system issues.
* Communicating CSV requirements to senior management and stakeholders.
1. Audit and Regulatory Support:
* Supporting external audit programs for vendors.
* Interfacing with regulatory agencies.
1. 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
1. · Direct experience in leading, managing or participating in CSV projects in GxP environments.
2. · B.Sc. degree in Computer Science, Chemistry, or a relevant scientific field with substantial relevant progressive experience (greater than 3 years).
3. · Extensive experience in regulated industries with comprehensive working knowledge of GxP, 21 CFR Part 11, OECD 17, and EU Annex 11 compliance requirements.
4. · GLP /GCP /GMP experience is preferable.
5. · Experience in supporting regulatory inspections.