Essential Functions

QA approver for internal computer system validation efforts. Act as liaison to the business for guidance and consultancy on system validation. Support computer system audits for review of SDLC and data integrity controls. Review CAPA and verification of CAPAs of system audits. 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.
• Knowledge of coding matrix and complexity measurements/determination.
• Minimum 8 years experience in Pharmaceutical industry or similar.
• Familiarity with regulations governing software development and validation.
• Knowledge of Statistical Programming is preferred but not required.
• Knowledge of GCP/GMP is preferred.
• Auditing experience is preferred but not required.
• Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently.
• Ability to Travel (approximately 10-20%).
• Location: Nutley (hybrid role)