We are looking for a Senior Software Validation Analyst to join our Quality & Business Excellence team in India. This is an amazing opportunity to work on the Quality and Compliance aspects of all of Clarivate’s GxP offerings in the Life Sciences and Academia & Government business lines. The team consists of 6 colleagues and is reporting to the V.P., Quality & Business Excellence. We have a great skill set in GxP Quality, regulatory compliance, computerized systems validation (CSV), ISO and other industry standards/best practices and we would love to speak with you if you have skills in providing quality-related guidance and governance to software validation projects. About You – experience, education, skills, and accomplishments EducationBachelor’s degree, preferably in a life sciences discipline. Equivalent experience may be accepted in lieu of a degree.Experience3-5 years current experience in a software/Computer Systems Validation (CSV) role within the pharmaceutical or life sciences industriesDemonstrated above average written communication skills in the English languageMust be familiar with US and EU regulations and guidanceAdditional Skill SetStrong interpersonal and communication skills, both verbal and writtenStrong organizational and leadership skillsAbility to maintain professional and positive attitudeMust be highly motivated and able influence and motivate othersProficient at problem-solvingAbility to manage multiple tasks effectively & efficientlyIt would be great if you also had . . . 3-5 years current experience in creating and maintaining SOPs preferredProven ability to work with and direct diverse and cross-functional teams to accomplish goalsThe ability to interact confidently with department heads and other senior leadership regarding corporate complianceWhat will you be doing in this role? Working directly with members of Quality Management, particularly with the Manager of Software Quality Assurance, and other internal teams to ensure the accuracy and consistency of system software development validation deliverables, as well as to proactively communicate status of validation undertakings, including communication of any identified barriers to management.Assisting with authorship and conduct of other assigned pre- and/or post-review/approval activities related to computer systems Validation documentation. This includes, but is not limited to, System Risk Assessments, 21 CFR Part 11 Assessments, Computer Validation Plans, Test Plans, Test Reports, Requirement Specifications, Release Memos and Validation Summary Reports.Supporting and/or conducting Validation efforts for all internal projects, as assigned.Fostering Validation knowledge both for development teams as well as the wider Clarivate audience; developing and/or providing training related to software validation.Ensuring a high degree of Inspection Readiness for Systems in CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within CSV responsibilityUtilizes expert knowledge in identification and management of risks pertinent to computer systems validation practices within a regulated landscape.About the Team The Quality & Business Excellence team oversees the entire Quality Management System (QMS) with regard to our directly or indirectly GxP-regulated software offerings. We work closely with all other functions of the business, including (but not limited to) Technology/Development, IT/infrastructure, Risk Management office, Information Security, Operations, Finance, and Legal. The team currently consists of 6 deeply experienced Quality Management professionals, across geographies in the U.S., U.K., and India.Hours of Work Full time; permanent; flexible working hours as long as obligations are metAt Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.
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