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CSV

Company: Apex Systems
Location: Bethlehem
Posted on: August 2, 2020

Job Description:

The CSV specialist will use hisher knowledge of FDA cGMP and related regulations and guidelines, and specific knowledge of computer validation methodologies and principles to perform CSV on a variety of systems and programs. Responsibilities include the following Designs, modifies, develops, writes, reviews and implements all Computer System Validation (CSV) documents, protocols and reports for validation and qualification work. Validates and coordinates all validation activities (Commissioning, Qualification, and Validation) by constant communication with affected departments and personnel oversees and reviews validation area processes and procedures. Generate Standard Operating Procedures (SOP) for computerized and manufacturing systems. Generate changes reports or documents for new or modified equipment Requirements At least 5 years of Computer System Validation required including experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report). Experience with Waters NuGenesis system and understanding of data integrity requirements a plus. EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservicesapexsystemsinc.com or 844-463-6178.SDL2017

Keywords: Apex Systems, Bethlehem , CSV, Other , Bethlehem, Pennsylvania

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