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Business Consulting : Computer System Validation

Business Consulting : Computer System Validation

ConfidentialHyderabad / Secunderabad, Telangana, Bengaluru / Bangalore, Chennai
9 days ago
Job description

We are seeking a highly skilled Business Consulting : Computer System Validation professional to lead project compliance workstreams. The ideal candidate will be responsible for the end-to-end quality and compliance aspects of projects, ensuring successful delivery and client satisfaction.

Key Responsibilities

  • Lead project compliance work streams, overseeing the end-to-end quality and compliance aspects of a project.
  • Be responsible for validation deliverables, client buy-in, and reporting to ensure successful project delivery.
  • Engage with key stakeholders for day-to-day interactions with client teams.
  • Participate in practice development activities.
  • Establish, implement, and monitor quality management requirements to assure that IT projects meet quality and regulatory requirements.

Skills Required

  • Strong business consulting and excellent soft skills.
  • Proven success in and thorough understanding of Computerized System Validation (CSV) .
  • Knowledge of key Pharmaceutical compliance regulations such as 21 CFR Part 11, GxP, GAMP 5, and SOX IT .
  • Subject matter expertise in areas like Quality Management, document management, and Change Management .
  • Knowledge of various Validation tools and templates used in the pharmaceutical industry.
  • Working knowledge of Risk Management, periodic or control maturity assessment, and Audits .
  • Must have global client exposure and experience working in a Global delivery model.
  • Bachelor's / Master's degree, preferably in pharmaceutical sciences or a related field.
  • Skills Required

    computerized system validation , Quality Management, Document Management, Change Management, Risk Management, Audits

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    Computer System Validation • Hyderabad / Secunderabad, Telangana, Bengaluru / Bangalore, Chennai

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