Associate Ecompliance Specialist

Year    Hyderabad, Telangana, India

Job Description

Summary o Ensure implementation of the e-Compliance strategy and all applicable Novartis and regulatory requirements for all GxP regulated computerized systems and associated infrastructure.

  • Collaborate with the IT team to provide QA oversight for all the IT projects, ensuring regulatory compliance.
  • Conduct thorough review of all the system development lifecycle documents to ensure assurance before the IT solutions are getting deployed in Production.
  • Curious in learning various global Regulatory requirements relating to Computerized systems and curious in learning the emerging technologies to provide proactive compliance guidance to the IT colleagues.
  • Collaborate with cross-functional teams to ensure Inspection readiness for all the GxP IT systems throughout their lifetime.
  • Support the life-cycle of GxP computerized systems with periodic re-evaluation of the validation status, change controls, deviations management ensuring that relevant documentation is in place and maintained according to the Novartis requirements.
  • Provide the needed e-Compliance support for the Strategic IT Projects
  • Support the measurement of Key Quality Indicators (KQI) and execution of Data Integrity (DI) Plan.

Major accountabilities:
  • Ensure implementation of the e-Compliance strategy and all applicable Novartis and regulatory requirements for all GxP regulated computerized systems and associated infrastructure.
  • Collaborate with the IT team to provide QA oversight for all the IT projects, ensuring regulatory compliance.
  • Conduct thorough review of all the system development lifecycle documents to ensure assurance before the IT solutions are getting deployed in Production.
  • Curious in learning various global Regulatory requirements relating to Computerized systems and curious in learning the emerging technologies to provide proactive compliance guidance to the IT colleagues.
  • Collaborate with cross-functional teams to ensure Inspection readiness for all the GxP IT systems throughout their lifetime.
  • Support the life-cycle of GxP computerized systems with periodic re-evaluation of the validation status, change controls, deviations management ensuring that relevant documentation is in place and maintained according to the Novartis requirements.
  • Provide the needed e-Compliance support for the Strategic IT Projects
  • Support the measurement of Key Quality Indicators (KQI) and execution of Data Integrity (DI) Plan.
Key performance indicators:
  • Customer satisfaction, punctuality rate -Jobs done on time, following the specified cycle time -Consistent compliance with GxP and Health, Safety and Environment guidelines and Standard Operating Procedures -No complaints with regulatory inspections
Minimum Requirements:
Work Experience:
  • Functional Breadth.
Skills:
  • Compliance Requirements.
  • Continuous Learning.
  • Dealing With Ambiguity.
  • Gxp.
  • Industry Standards.
  • Quality Standards.
  • Self Awareness.
  • Technological Expertise.
Languages :
  • English.
Skills Desired Compliance Requirements, Continued Learning, Dealing With Ambiguity, Gxp, Industry Standards, Quality Standards, Self-Awareness, Technological Expertise

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Job Detail

  • Job Id
    JD3824561
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Hyderabad, Telangana, India
  • Education
    Not mentioned
  • Experience
    Year