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IT Compliance - Business Analyst / Advanced Business Analyst Bengaluru India,  

Novo Nordisk (company)


Posted on : 20 March 2017

Project Description


Job Description
  •  IT Shared Services (ITSS) team in our company  is a unit of the Corporate IT India comprising of talented IT specialists colleagues and growing fast.  
  • CORPORATE IT India is an integral part of IT, Quality & Corporate Development in Denmark which currently consists of approximately 300+ highly skilled IT professionals worldwide responsible for all major IT projects and IT systems in our company.
  •  ITSS offers services to provide compliance/validation activities to the internal line of businesses within company globally. 
  • ITSS works closely with System managers, ITQCs, subject matter experts and colleagues in the other areas of IT Shared Services/other departments in Denmark as well as with the company IT organisation in India. 



Job:
  • Perform compliance related tasks provided as services from the department
  • Develop plans, execute and deliver the services with acceptable service evaluations.
  • Perform stakeholder management as a part of delivering services involving multiple stakeholders.
  • Able to perform CAPA and RCA using 5 x Why approach or any similar approach
  • Able to take up IT Quality co-ordinator and Validation Responsible roles at various stages of IT project.
  • Should be able to provide compliance consulting for the IT projects at every stage of a V-Model development
  • Collaborate with stakeholders/partners with diverse interests, knowledge, cultural background and personality.
  • Excellence in CSV understanding
  • Awareness in ITIL concepts including Incident/Problem and Change Management
  • Efficiently author / review yearly reports with respect to User Setup and Configuration Management
  • Efficiently author / review Validation Status Summary Reports
  • Handle Nonconformities and/or Remarks for IT Systems
  • Internal audit support and facilitating the closure of the identified Audit NCs
  • Test coordination / validation for system corrections / system releases
  • Demonstrate resourcefulness and ownership
  • Manage time planning for tasks Communicate and involve relevant stakeholders 



Qualifications (minimum requirements):
  •  M.Sc., B.Sc. or similar graduate degree in relevant field (Computer Science or equivalent)
  • Excellent communication skills in English and comfortable working with different cultures 


Experience:
  • Min 5+ years of experience in working in the IT quality domain.
  • Min 4+ years in performing RCAs, CAPA and any other relevant IT compliance/validation activities.
  • Min 2+ years of practical experience in GxP areas with exposure to regulatory affairs.
  • Min 2+ years of experience in validation activities of a IT Project in a pharma domain 


Leadership competencies expected:
  •  Live the company values and be a role model to employees
  • Quality Mind-set and should be able to advice/challenge decisions in the interest of quality
  • Keep an up to date knowledge on IT service management through various industry framework
  • Foster innovation and continuous improvement in the department
  • Inspire and motivate employees
  • Collaborate across boundaries 

Locations

India Bangalore

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