Cyber-CSV

2 days ago

Pune, Maharashtra, India Talent Worx Full time

We're hiring for one of the world's leading professional services firms, renowned for its commitment to innovation, excellence, and global impact. With a presence in over 150 countries, this organization provides services across consulting, audit, tax, risk advisory, and financial advisory — helping Fortune 500 companies and governments navigate complex challenges.

Requirements

Key Job Responsibilities:

  • Support on IT quality systems framework design and implementation
  • Managing the reviews and assessments for IT quality
  • Assist in Computer System Validation (CSV) compliance of GxP processes for pharmaceutical companies or experience on quality compliance services for global consumer health care, medical devices, and pharmaceutical companies
  • GxP Business process review
  • Development of integrated GxP and IT compliance
  • Standard operating procedures and guidelines
  • GxP and IT compliance assessment
  • Define the Validation strategy of IT Software and Systems
  • Actively participate in the Validation Life Cycle of regulated IT projects or platforms by planning validation deliverables, working on validation documentation, participating in authoring deliverables, functional requirements definition, traceability matrix, validation protocol development,
  • Validation testing and deviation management; and working closely with cross-functional project teams.
  • Ensure 21 CFR Part 11 compliance for Computerized system
  • Provide User training on CSV and increase awareness about compliance
  • Responsible for reducing Gaps identified in various GAP/Risk Assessments existing and new computerized systems and providing a remedial action plan for compliance.
  • Carrying out an Audit of IT systems to ensure regulatory compliance
  • Manage the specified business/systems requirements, working closely with the designated Project Manager to facilitate the progress of the project Coach/mentor staff and provide technical leadership, as needed

The key skills required are as follows:

  • IT Quality, Regulatory, Compliance (IT-QRC)
  • Quality guidelines mentioned by FDA, MHRA, and other regulatory bodies
  • GxP practices and GAMP5 guidelines.
  • Computer System Validation of various COTS products like COGNOS, IMPACT, BAELN and other related applications used in pharmaceutical industries
  • Experience in activities like Business Analysis, Risk Identification, FRS creation and other validation testing deliverables.
  • Good understanding & practical experience of 21CFR Part 11 and other FDA GxP regulations.

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