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Sr. Analyst- Validation, Qualification of IT applications, GXP, Service management

Job Location: Electronic City, Bangalore

Shift Timings: 1:30 pm – 10:30 pm

The R&D Application team supports the delivery of the R&D service Portfolio for the HealthCare Research (Global Discovery Technology, Global Early Development, External Innovation, Patents & Scientific Services) and Development (Strategic & Business Operations, Global Clinical Development, Global Regulatory Affairs & QA, Global Medical Affairs & Safety).You will work within the Business Technology (BT) group, as part of the R&D domain organization, covering Biopharma, Consumer Health and assisting as needed with Life Science and Performance Materials. As R&D Qualification Owner, you enable the application delivery team to stay compliant by providing efficient approaches and Services. The Qualification Owner is a Orgn employee authorized to manage the Qualification lifecycle of an IT Infrastructure component (e.g. IT System)

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Responsibilities:

  • Preserve the qualified state of the IT Infrastructure component all over its
    lifecycle;
  • Create and maintain the qualification documents, as appropriate;
  • Responsible for managing the progress of the qualification, about the plan, in
    close contact with the IT Service Provider and the Service Delivery Manager
  • Support the assessment of the proposed suppliers for their impact on
    qualification of the IT Infrastructure component;
  • Support the on-going regulatory compliance of the IT components for defined
    services;
  • Review and approve regulatory system changes and documentation;
  • Responsible for the operational tasks of IT Quality Assurance including audit
    responsibility;
  • Conduct periodic review(s) as part of the periodic review of the entire system
    and compile related reports during operation phase;
  • Be the accountable point of contact in matters associated with the qualification.

Minimum Qualifications:

  • Minimum of 6-10 years of experience
  • Minimum of Associates Degree or applicable experience within information
    systems with focus on Qualification of R&D applications
  • Previous experience in the biotechnology / pharmaceutical or related industry
    implementing and validating computer systems that manage regulated
    information
  • Working knowledge of IT infrastructure qualification processes and IT operating
    procedures
  • Knowledgeable in 21 CFR Part 11, GCP and GLP regulations
  • Thoroughly familiar with Quality & GxP IT compliance requirements
  • Excellent analytical skills sufficient to lead complex problems resolution, make
    accurate and consistent interpretations and present high-level reporting for
    weekly operations meetings and monthly service reviews.
  • Ability to familiarize himself / herself independently with entirely new subjects
    and thus provide comprehensive and innovative solutions
  • Excellent written and verbal communications skills
  • Working knowledge of information security and best practices
  • Proven fast learning & problem management skill
Job Requisition ID:  212082
Location:  Bangalore
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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