Preparation of Validation protocols for GxP critical reports. Assist in protocol execution, review and approval. Generation of Change requests and IT tickets for the validation of reports. Validation of business intelligence reports and skilled with all the tests required to properly qualify the reports. Review existing SOPs and prepare draft to serve as the framework for Computer System Validation Projects. Develop and execute documentation for validation and qualification activities to support various computer system validation projects. Documents to be authored may include URS, FRS, FRA, HLCCD, etc. Solve problems during validation process and address/advise on issues such as deficiencies, deviations and change control, etc. Ensure compliance of computerized systems to relevant regulatory requirements (e.g. cGMP/GLP/GAMP/GALP). Draft templates for High level Risk Assessments, User Requirements Specification, Validation Plan and Validation Summary Reports. Prepare Validation Plans, IQ, OQ, Validation Summary Reports. Acts as liaison between Quality Assurance and project team to assure that GxP software is implemented in compliance with applicable regulations and guidelines. Attend meetings to assist in the development of a validation remediation strategy. Previous project management experience required. PQM experience preferred. Minimum Requirements: Bachelor s degree in business/technical area or comparable education/experience A minimum of 5 years experience in Computer Systems Validation within the pharmaceutical/biotechnology GMP environment including authoring and execution of IOQ/PQ s, experience in performing traceability matrices, risk assessments Solid understanding of Computer Systems Validation of Manufacturing and Packaging systems Working knowledge of regulations, such as 21CFR Part 11, Good Automated Manufacturing Practice (GAMP5), GLP and Good Automated Laboratory Practice (GALP) Must have strong hands-on, end-to-end CSV project experience and application of project controls - including familiarity with all project lifecycle phases from requirement gathering through delivery, issues/risk management, change management, release management. Solid understanding of data integrity risks Ability to manage complex projects and timelines in a matrix team environment Ability to independently identify compliance risks and escalate when necessary
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