10+ years in computer systems validation activities
7+ years in GMP/GxP regulated environments
Experience developing full validation documentation and testing protocols
Familiarity with FDA 21 CFR Part 11
Experience validating Enterprise systems (SAP, MES) and Life sciences systems (Veeva, Trackwise, Argus)
Knowledge of test management tools (Microfocus ALM, ValGenesys)
Understanding of CSA (Computer System Assurance)
Responsibilities
Lead validation strategy development and implementation
Oversee document creation and reviews for validation
Ensure scalability and maintainability of validation documentation
Conduct compliance assessments regarding FDA regulations
Coordinate validation activities for enterprise-level systems
Manage test protocols across SDLC phases
Develop and maintain relationships with cross-functional teams
Benefits
Flexible work environment
Professional development opportunities
Collaborative team culture
Health and wellness programs
Career advancement potential
Full Job Description
About the job Computer Systems Validation Lead
At least 10 years of experience supporting and/or performing all aspects of computer systems validation activities including development of scalable validation strategies, documents, and perform document reviews
At least 7 years prior experience in computer systems validation within GMP/GxP regulated environments
Proven experience developing full validation documentation and testing protocols within the various SDLC phases that is scalable and maintainable to demonstrate continuous compliance
Experience with FDA 21 CFR Part 11
Experience with the validation of Enterprise systems SAP and/or MES system Preferred. Validation of Life sciences systems such as Veeva, Trackwise, Argus, Clnical, Quality systems highly desired.
Broad understanding of the test management Tools, including experience and knowledge Microfocus ALM, ValGenesys etc preferred.
Knowledge and experience around CSA highly preferred.
About RxCloud
RxCloud Careers
Joining RxCloud presents an unparalleled opportunity to become part of a leading team of professionals dedicated to pioneering innovations in the healthcare technology sector. RxCloud is renowned for its commitment to diversity, leadership, and professional growth, making it an ideal workplace for ambitious individuals looking to advance their careers.
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RxCloud offers a variety of job opportunities that cater to a range of skills and experiences. Whether one is seeking an entry-level position or a more senior role, RxCloud is keen on hiring top talent to join their dynamic team. The company values curiosity, creativity, and solution-driven team players.
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Kickstart a career in healthcare technology with an internship at RxCloud. Internships provide invaluable industry experience and a chance to develop professional skills in a real-world setting. RxCloud’s internship programs are designed to foster innovation and provide hands-on training that prepares interns for future employment.
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The culture at RxCloud is built on a foundation of inclusivity and diversity. The company believes that a diverse team leads to better innovation and more effective problem-solving. Diversity training is integral to RxCloud’s ethos, ensuring that all team members feel valued and understood.
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Employees at RxCloud enjoy a range of benefits designed to enhance their work-life balance and job satisfaction. These benefits include competitive salaries, health insurance, retirement plans, and more. RxCloud recognizes the importance of providing a supportive environment where employees can thrive both professionally and personally.
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