Search Jobs
Clinical Systems Quality-III
Job Description
Essential Functions
- Participate in computer systems and vendor audits for review of their validation (fit-for-purpose) and data lifecycle controls.
- Review CAPA and verification of CAPAs of system and vendor audits.
- QA Representative for internal validation efforts.
- Act as liaison to the business for guidance and consultancy on software validation fit for purpose .
- Support health authority audits/inspections for inspection readiness.
Requirements
- Bachelor s degree in associated functional disciplines including IT, Data Sciences and others.
- Software development familiarity with both Agile and Waterfall methodology.
- Minimum 7 years' experience Computerized System Validation (CSV) experience
- Minimum 5 years' experience in Pharmaceutical industry or similar.
- Minimum 3 years' experience Vendor / Computerized System Validation (CSV) Auditing experience
- Knowledge of ICH GCP, clinical trial methodology, and specific knowledge of software validation regulations/guidance (including 21 CFR Part 11)
- Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently.
Meet Your Recruiter
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About Nutley, NJ
Staffing Leader of the Year Anju Abel
CEO, LanceSoft
LanceSoft is proud to announce that its Chief Executive Officer, Anju Abel, has been honored with the prestigious "Staffing Leader of the Year" award at the 2025 TIARA Staffing Awards US. The award recognizes her visionary leadership and significant contributions to improving staffing processes, employee engagement, and workforce outcomes.
Anju Abel's leadership has been instrumental in transforming LanceSoft's global staffing operations. Her focus on innovation, employee satisfaction, and client-centric delivery has led to higher retention rates, a motivated workforce, and enhanced operational efficiency.
"This award is a testament to the incredible team at LanceSoft and our unwavering commitment to redefining staffing solutions," said Anju Abel. "I'm honored to receive this recognition and proud of the impact we continue to make in the lives of our clients and talent worldwide."
The judging panel highlighted Anju's ability to consistently deliver outstanding client success stories, exceed expectations, and foster professional development within her team. Her active community involvement and dedication to advancing the staffing industry were also key factors in her selection.
TIARA Awards are known for celebrating excellence, innovation, and achievement in the talent acquisition sector, and this accolade places Anju among the top leaders reshaping the future of workforce solutions.