Computer Systems Validation Lead

RxCloud$120K — $150K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • 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
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.

Explore Job Opportunities

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.

Internship Programs

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.

Professional Growth and Development

RxCloud is committed to the professional growth of its employees. The company offers comprehensive benefits and resources to support career advancement and personal development. From leadership training and workshops to networking events, RxCloud invests in its team members to help them reach their full potential.

Inclusive Culture and Diversity

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.

Benefits of Working at RxCloud

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.

Applying for a Position

To apply for a position at RxCloud, candidates should prepare their resume to highlight relevant experience and skills. The interview process at RxCloud is designed to assess not only professional qualifications but also a candidate's fit within the company culture and team. Interested candidates can explore open positions and submit their applications through the RxCloud Careers page.

Stay Connected with RxCloud Careers

Stay informed about the latest news, job alerts, and career tips from RxCloud by subscribing to the Careers Blog. This resource offers insider perspectives and industry-leading insights that can be immediately applied, keeping one ahead in the fast-evolving field of healthcare technology.

Join the RxCloud Team

Search for open positions that match individual skills and interests on the RxCloud Jobs portal. RxCloud is looking for passionate, driven, and innovative professionals to join their team and help shape the future of healthcare technology.

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