Job Title: Software Validation Quality
Location: Nutley NJ - Hybrid
Duration: 12 months
Job Description
The Software Validation Quality Consultant will work closely with the Clinical Quality Assurance Systems Lead to support internal validation efforts and audits of our vendors and computerized systems.
Key Responsibilities
- Conduct audits of computer systems and vendors, assessing their Quality Management System, SDLC, validation, and data integrity.
- Review and verify CAPAs from audits.
- Approve internal validation efforts.
- Provide guidance on software validation.
- Support inspection readiness for health authority audits.
Education And Experience
- Bachelor’s degree in IT, Data Sciences, or related field.
- 3-5 years of experience in the pharmaceutical industry or similar.
- 1-3 years of experience in CSV Auditing.
- Familiarity with Agile and Waterfall methodologies.
- Knowledge of software validation regulations.
- Preferred knowledge of GCP/GMP.
- Strong communication and time management skills.
Skills
- Clinical quality assurance
- Validation
- SDLC
- CAPA
- Agile and Waterfall methodologies
- CSV
- GCP/GMP