IT QA

KAYGEN is an emerging leader in providing top talent for technology-based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project-based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries.

STANDARD FORMAT FOR ALL JOB POSTINGS

Job Title: IT QA / QA eCompliance Manager
Location: US - Indianapolis (preferred) Onsite/Remote
Duration: 6

Job Description:

• This Computer Systems Quality Assurance role will be responsible for supporting the expansion of client's ERP systems and associated applications to new and existing manufacturing sites. The role will deliver quality oversight to ensure assigned systems are developed and maintained, in compliance with corporate Computer System Validation (CSV) standards.
  Key Objectives/Deliverables:
  • Maintain Inspectional Readiness
  • Ensure supported systems are validated
  • Ensure all quality actions and commitments for supported areas are appropriately tracked in Quality/CAPA plans
  • Participate in self-inspections, audits, and supplier assessment activities to ensure the state of computer system validation is clearly and accurately understood
  • Ensure all Inspection Readiness materials are current and appropriate
  • Deliver Projects, Programs, and Support
  • Provide consulting and interpretation on client processes as related to the supported computer system
  • Provide training to customer areas on CSV-related topics as needed
  • Partner with Business, Business Quality, and IT customer areas to deliver business value
  • Understand customer, company, and Quality priorities
  • Review/approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completed
  • Engage customers and QA management in appropriate discussions of risk management
  • Ensure suppliers of computer systems or services meet quality expectations
  • Escalate computer system quality issues to the appropriate persons
  • Strive for and promote consistency within the CSQA Organization
  • Streamline and Continuously Improve
  • Eliminate non-value-added activities in order to focus on activities which continuously improve assurance of quality
  • Identify opportunity for streamlining and simplification and assist in developing improved solutions
  • Understand external trends and potential ramifications for the supported IT area(s)

Requirements:

• IT CSV - Validation of IT systems
• IT QA / QA eCompliance Manager
• Experience validating Clinical Trials Management Systems (CTMS), Statistical Analysis Systems / Reports / Tools etc.
• Hands-on experience with Veeva Quality Docs, ServiceNow, JIRA and Client ALM
• Pharma industry experience is mandatory

• IT CSV - Validation of IT systems
• IT QA / QA eCompliance Manager
• Experience validating Clinical Trials Management Systems (CTMS), Statistical Analysis Systems / Reports / Tools etc.
• Hands-on experience with Veeva Quality Docs, ServiceNow, JIRA and Client ALM
• Pharma industry experience is mandatory

At KAYGEN, we are always looking for dynamic, talented and experienced individuals. We invite you to join our team of talented IT professionals, consulting at client locations across the globe. Our culture is team-orientated; we strive to stand by our core values of respect, honesty and integrity. Our team of experienced staffing experts will work with you to find you the best opportunity. For more information, please visit us at www.kaygen.com.

Benefits:

• Free Healthcare Insurance
• Vision and Dental Insurance
• 401(k) Retirement Plan
• Free Life Insurance
• Sick Time Off

Achieve your Kaizen by clicking here. A unique and exclusive talent community supported by Kaygen, that includes programs like:

• Certifications

• Mentorship Program
• Referrals
• Family and Wellness benefits
• Continuous Growth and Career Development

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