Gxp Compliance

Description CTG is seeking to fill a GxP Compliance Validation Specialist opening for our client Location Remote Duration 12 months Duties Lead GxP Computer System Validation CSV and Computer System Assurance CSA activities for cloud-based IT systems in Pharma Life Sciences Develop review and manage validation deliverables Validation Plans IQ OQ PQ protocols Risk Assessments Traceability Matrices Test Scripts and Summary Reports Ensure compliance with GAMP 5 21 CFR Part 11 and Annex 11 Manage validation efforts for periodic cloud platform releases and support QMS processes including deviation management CAPA and change control Collaborate with IT QA and business teams maintaining inspection-ready documentation Skills Expertise in GxP-regulated IT system validation and CSA principles Experience with cloud-based ELN LIMS platforms Benchling preferred Strong documentation communication and stakeholder management skills Nice to Have Skills Test Summary Reports Risk Assessments Configuration Verification Traceability Matrices Familiarity with Veeva Vault Docs QMS and ServiceNow SNOW Track record of high approval rates and audit-ready documentation Experience Proven experience managing validation efforts for GxP-regulated cloud platforms with periodic releases Education Bachelor s degree in Life Sciences Computer Science or related field preferred Excellent verbal and written English communication skills and the ability to interact professionally with a diverse group are required CTG does not accept unsolicited resumes from headhunters recruitment agencies or fee-based recruitment services for this role To Apply To be considered please apply directly to this requisition using the link provided For additional information please contact Laura Dominguez at Kindly forward this to any other interested parties Thank you The expected base salary for this position ranges from 59 00 to 74 00 hour Salary offers are based on a wide range of factors including relevant skills training experience education market factors and where applicable licensure or certifications obtained In addition to salary a competitive benefit package is also offered About Us CTG a Cegeka company is at the forefront of digital transformation providing IT and business solutions that accelerate project momentum and deliver desired value Over nearly 60 years we have earned a reputation as a faster and more reliable results-driven partner Our vision is to be an indispensable partner to our clients and the preferred career destination for digital and technology experts CTG leverages the expertise of over 9 000 team members in 19 countries to provide innovative solutions Together we operate across the Americas Europe and India working in close cooperation with over 3 000 clients in many of today s highest-growth industries For more information visit Our culture is a direct result of the people who work at CTG the values we hold and the actions we take In other words our people define our culture It s a living breathing thing that is renewed every day through the ways we engage with each other our clients and our communities Part of our mission is to cultivate a workplace that attracts and develops the best people reflected by our recognition as a Great Place to Work Certified TM company across many of our global operations CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local state and federal laws CTG is an Equal Opportunity Employer CTG will assure equal opportunity and consideration to all applicants and employees in recruitment selection placement training benefits compensation promotion transfer and release of individuals without regard to race creed religion color national origin sex sexual orientation gender identity and gender expression age disability marital or veteran status citizenship status or any other discriminatory factors as required by law CTG is fully committed to promoting employment opportunities for members of protected classes