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Specialist II IT Validation Services

2 weeks ago

Hyderabad, Telangana, India Bristol-Myers Squibb Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Position SummaryKey Responsibilities
  • Support execution of Qualification activities as it relates to infrastructure applications and hardware in a timely manner
  • Support validation lead in conducting risk & impact assessment to determine the extent of validation and qualification
  • Author CSV deliverables including but not limited to Plans & Summary Reports
  • Support the SDLC process as it relates to application validation and infrastructure qualification
  • Review and approve change tickets for applications and ensure alignment with change management process.
  • Conducts periodic reviews of applications to ensure applications remain in a state of compliance.
  • Provides regular status updates to one up manager and escalates any potential issues in a timely manner
Qualifications & Experience
  • Minimum Bachelors degree and 2-4 years of experience in IT Quality, Computer System Validation and/or related field.
  • Experience supporting validation of one or more of the following systems (desirable): SAP, ServiceNow, Veeva, Regulatory Submission systems
  • Experience in change management process
  • General knowledge (desirable) of IT applications, IT infrastructure, architecture of computer systems including cloud as well as networks, operating systems, databases, and software tools
  • Good knowledge (mandatory) of IT testing practices and methodologies in the Pharma GxP space-and good working knowledge of test management tools like ALM etc.
  • Familiarity with test automation tools desirable
  • Understanding (desirable) of Electronic Records and Electronic Signature regulations, Data Integrity principles, GAMP and Agile methodologies
  • Works predominately within established procedures
  • Ability to work under minimal supervision
  • Demonstrates openness to learning and developing. Takes a responsibility for their own development and growth
  • Good English verbal and written communication skills including the ability to write clear and precise documentation

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