Job Title : Software Validation Quality Consultant
Duration : 12 Months+ (possibilities of Extension)
Location : Nutley, NJ 07110 (Hybrid 2 days onsite)
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 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.
- Location : Nutley or hybrid.
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