Senior Business Solutions Expert

1 week ago

Delhi NCR Kolkata, India beBeeBusiness Full time US$ 90,000 - US$ 1,20,000
Senior Business Solutions Expert

We are seeking a highly skilled Senior Business Solutions Expert 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.
Required Skills and Qualifications:
  • 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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