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Quality Assurance Senior Analyst - Software Validation and GCP

Date: Oct 13, 2021

Location: Pune, MH, IN

Company: Cytel Inc

Summary of Job Responsibilities:

The Quality Assurance Senior Analyst works within the Quality Assurance Team performing a variety of assigned quality, data related tasks and projects.

General responsibilities:

    • Support the development and maintenance of Cytel’s QA systems as appropriate.
    • Understand, comply with and promote core operating procedures and working instructions.
    • Perform activities associated with various one-time or on-going projects.
    • Maintain the integrity of all QA data.

Specific responsibilities:

  • Assists with Quality Event (deviation, breach, complaint, issue) and CAPA program and documentation.
  • Assists with Vendor Qualification activities and documentation.
  • Assist in the development and implementation of QA metrics.
  • Participate in, manage and support client and internal audit and assessment activities, regulatory inspections and vendor qualifications.
  • Analyze and design new or modified Quality Assurance (QA) procedures and standards.
  • Lead QA effort for projects and coordinate rollouts.
  • May provide coaching and guidance to other team members.
  • Verifies the accuracy and completeness of information within various systems that support our business.
  • Assist in supporting Cytel staff in QA or Regulatory related request.
  • Other duties as assigned.

 

  • Skills:
    • Analytical thinking and troubleshooting skills
    • Possess a strong working knowledge of:
      • Good Clinical Practices (GCP)
      • ICH Guidelines
      • Software Validation requirements
      • 21 CFR Part 11, Annex 11, and other applicable regulations.
    • Complex problem-solving skills.
    • Ability to multitask and efficiently manage time.
    • Excellent verbal and written communication.
    • Must be detail oriented.

Proficient in Microsoft office tools – Excel, Word, etc.


Job Segment: Developer, CAPA, Quality Assurance, QA, Quality, Technology, Management