Hello
Hope you are doing great.
This is Yamuna Vicharapu from Intellectt INC; we have an immediate opportunity. Please find the below job description and if you are interested, please forward your resume to yamuna@intellectt.com or call me at 732 797 9802.
Title: Software Validation Quality Consultant
Location: Hybrid at Nutley NJ
Industry : pharma/medical
Job Description
The Software Validation Quality Consultant will work closely with the clinical quality assurance systems lead to deliver on internal validation efforts and audits of *’s vendors and computerized systems.
Essential Functions
- Participate in computer system and vendor audits for review of their Quality Management System, SDLC, including validation, and data integrity controls.
- Review CAPA and verification of CAPAs of system and vendor audits.
- QA approver for internal validation efforts.
- Act as liaison to the business for guidance and consultancy on software validation.
- 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 3-5 years' experience in Pharmaceutical industry or similar.
- Minimum 1-3 years' experience Vendor / Computerized System Validation (CSV) Auditing experience
- Knowledge of regulations governing software validation and development.
- Knowledge of GCP/GMP is preferred.
- Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently.
- Ability to Travel.