Overview
On Site
BASED ON EXPERIENCE
Contract - W2
Contract - Independent
Skills
CSV
COMPUTERIZED SYSTEM VALIDATION
GXP
GCP
GMP
Job Details
Our direct client a large pharmaceutical company is seeking to hire a Software Validation Quality Consultant for 6 months plus contract to work hybrid from their Nutley, NJ
Job Title: Software Validation Quality ConsultantDuration: 6 months plus
Location: Nutley, NJ | Hybrid - must be a local candidate willing to come on site at least 2 days a week, with one of them being Wednesday (more, if needed).
- Looking for someone who has done Validation in the clinical space.
- Google Cloud Platform and CSV. Must understand the business of clinical.
Key Responsibilities:
- Conduct thorough reviews of validation documents.
- Assist in the creation and development of validation deliverables.
- Adapt to and excel in a dynamic and challenging work environment.
- Clearly articulate the significance of validation processes to non-specialist audiences.
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.
- 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 Google Cloud Platform/GMP is preferred.
- Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently.
- Medical for full time employees
- Dental, and Vision Insurance
- Life Insurance, Short-Term Disability, Long-Term Disability, etc.
Thank you!
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