Clinical Systems Quality-III

Clinical Systems Quality Professional

The Clinical Systems Quality (CSQ) professional will work closely with the CQA - CSQ lead to deliver on internal validation efforts and audits vendors and computerized systems.

Essential Functions

• Participate in computer systems and vendor audits for review of their validation (fit-for-purpose) and data lifecycle controls.
• Review CAPA and verification of CAPAs of system and vendor audits.
• QA Representative for internal validation efforts.
• Act as liaison to the business for guidance and consultancy on software validation – "fit for purpose".
• 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 7 years' experience Computerized System Validation (CSV) experience
• Minimum 5 years' experience in Pharmaceutical industry or similar.
• Minimum 3 years' experience Vendor / Computerized System Validation (CSV) Auditing experience
• Knowledge of ICH GCP, clinical trial methodology, and specific knowledge of software validation regulations/guidance (including 21 CFR Part 11)
• Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently.