Role: Software Validation Quality Consultant
Location: Nutley, NJ (Hybrid)
Role Summary
Work with the Clinical Quality Assurance Systems Lead to validate software and audit vendors.
Key Responsibilities
- Audit computer systems and vendors for quality, validation, and data integrity.
- Review and verify corrective actions (CAPAs) from audits.
- Approve internal validation efforts.
- Provide guidance on software validation to the business.
- Prepare for and support health authority audits and inspections.
Experience
- 3-5 years in the pharmaceutical industry or similar.
- 1-3 years in Vendor / Computerized System Validation (CSV) Auditing.
- Bachelor’s degree in IT, Data Sciences, or related fields.
Skills
- Knowledge of Agile and Waterfall software development.
- Understanding of software validation regulations.
- Preferred: Knowledge of GCP/GMP.
- Strong communication and time management skills.
- Ability to handle multiple projects.