At-a-Glance:

Are you ready to build your career by joining a global pharmaceutical company? If so, our client is hiring an IT Quality Validation Consultant.

Position Type:

• Contract
• Hybrid - Willing to come on site - 2-3 days a week.
  
  
  

Required:

• 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.
  
  
  

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.
• 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 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.
  
  
  

Get in Touch:

If you think you'd be a good match, submit your resume and reach out to Rishaw at 862-895-5483 to learn more.

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