Business Consulting : Computer System Validation

7 - 12 years

7 - 12 Lacs

Posted:8 hours ago| Platform: Foundit logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Business Consulting : Computer System Validation

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.

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