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Responsibilities
1. Validate computerized systems in accordance with 21 CFR Part 11, EU Annex 11, OECD 17, and GAMP 5.
2. Support CSV activities of the Quality Management System including deviations, CAPAs, and change controls related to GxP computerized systems.
3. Review and create validation documentation such as risk assessments, user requirements, validation plans, IQ/OQ/PQ documentation, traceability matrices, and validation summary reports.
4. Collaborate with cross-functional teams, including vendors, IT, Quality Assurance, and Operations, to ensure successful validation of computer systems and software applications.
5. Identify and resolve system issues effectively, communicating gating items to senior management and stakeholders.
6. Support the external audit program for vendors related to GxP computerized systems.
7. Interface with regulatory agencies and audits as required, presenting validation strategies and justifying risk-based decisions.
8. Review and approve validation documentation, ensuring accuracy, completeness, and compliance with regulatory requirements and company policies.
9. Continuously improve the CSV process by identifying areas for enhancement and implementing best practices.
Skills, Education & Qualifications
* B.S. degree in Computer Science, Engineering, or relevant scientific field.
* Minimum 2-4 years’ validation experience within regulated industries, with knowledge of GxP, 21 CFR Part 11, OECD 17, EU Annex 11, and GAMP 5.
* Experience with CSV, SDLC, and Data Integrity principles.
* Ability to stay current with industry trends, regulatory changes, and best practices to enhance CSV processes.
* Understanding of GCP, GLP, and GMP principles and procedures.
* Excellent verbal and written communication skills.
* Proficiency in MS Word and Office applications.
* Strong team player with the ability to work independently and cross-functionally, with analytical thinking and problem-solving skills, adaptable to changing priorities.
Seniority level
* Associate
Employment type
* Full-time
Job function
* Information Technology
Industries
* Biotechnology Research and Research Services
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