Senior Technology Quality Assurance Specialist

2 weeks ago

Nagpur, Maharashtra, India Parexel Full time

Job Summary

Parexel is seeking a Senior Technology Quality Assurance Auditor to join our team. As a Senior Technology Quality Assurance Auditor, you will play a crucial role in conducting audits that impact business operations, processes, and systems, contributing to meeting client needs and maintaining high compliance standards.

Key Responsibilities

  • Lead, perform and report audits
  • Manage Technology audits
  • Lead and coordinate internal audit programs (global and regional)
  • Support Serious Breaches
  • Support auditor training and Mentoring
  • Maintain QA records / systems
  • Support Sponsor Audits and Regulatory Inspections
  • Maintain sound knowledge of Parexel policies, procedures, and guidelines and promote compliance within Parexel
  • Build, develop, and maintain working relationships with internal and external customer groups

Requirements

  • Excellent interpersonal, verbal and written communication skills
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
  • Experience with Microsoft based applications and ability to learn internal and supplier computer systems
  • Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork
  • Ability to develop relationships with culturally diverse stakeholders, including Parexel team members and sponsor representatives
  • Ability to work professionally with highly confidential information
  • Flexibility and ability to adjust to changing priorities and unforeseen events
  • Excellent time management skills and the ability to follow-up on multiple tasks and projects
  • Ability to diplomatically address sensitive issues confidentially and professionally
  • Ability to work consistently in a fast-paced environment

Education and Experience

  • Strong knowledge of GxP, industry standards, applicable international technology compliance regulations
  • Must be detail oriented and able to maintain a 'big picture' overview during a sponsor audit or inspection
  • Ability to follow up on multiple tasks and projects, and to handle confidential information diplomatically
  • Familiar in technology as it relates to clinical trial activities, including System Life Cycle process and applicable GCP regulations pertaining to Computer Systems

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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