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CSV Team Lead
1 month ago
Responsibilities
1. Leadership and Team Management:
o Leading the global CSV team.
o Providing guidance, training, and support.
o Must be hands-on as both part of the CSV process as well as actual validation performance.
2. Oversight and Compliance:
o IT CSV oversight for GXP computerized systems.
o Ensuring compliance with regulations (21 CFR Part 11, GMP Annex 11, OECD 17, GAMP 5).
o Handling deviations, CAPAs, and change controls.
3. Documentation and Review:
o Creating and reviewing validation documentation.
o User requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, traceability matrices, and validation summary reports.
4. 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.
5. Issue Resolution and Communication:
o Identifying and resolving system issues.
o Communicating gating items to senior management and stakeholders.
6. Audit and Regulatory Support:
o Supporting external audit programs for vendors.
o Interfacing with regulatory agencies.
7. 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.
Education, Experience & Skills Required
- Direct experience in leading, managing or participating in CSV projects in GxP environments.
- Necessary GLP/GCP experience; GMP experience is preferable.
- Experience in supporting regulatory inspections.
- B.S. degree in Computer Science, Chemistry, or a relevant scientific field with substantial relevant progressive experience (greater than 3 years).
- Extensive experience in federally regulated industries or CSV teams in Pharmaceutical/Biotech industry.
- Comprehensive expertise and working knowledge of GxP, 21 CFR Part 11, OECD 17, and GMP Annex 11 compliance requirements.
About Us
Are you interested in working in science for a leading global Contract Research Organization that is expanding rapidly and delivering best in class service to its clients? If you are ambitious and hard working then keep reading, as we are looking for talented individuals like you.
We are globally recognised for our leadership in science and, as a result, you will have the opportunity to work with some of our industries smartest and most inquisitive people, in a flexible and supportive environment. It is the ideal place to expand your knowledge, take on new responsibilities and make ambitious strides in your career.
If you want to join us to help us deliver our mission of using our scientific capabilities to improve the quality of life of people, then we would love to hear from you.
