Software Quality Engineer

Job Title: Software Validation Quality Consultant
Location: Hybrid at Nutley NJ
Duration: 12 months

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 the companys 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.

Education & Experience:

• Bachelors degree in associated functional disciplines including IT Data Sciences and others.
• Minimum 35 years experience in the Pharmaceutical industry or similar.
• Minimum 13 years experience in Vendor / Computerized System Validation (CSV) Auditing.
• Software development familiarity with both Agile and Waterfall methodology.

Skills:

• Software Validation
• Quality Management System (QMS)
• SDLC (Agile and Waterfall)
• CAPA
• Vendor/Computerized System Validation (CSV) Auditing
• GCP/GMP (preferred)
• Strong communication and time management skills