Senior IT Validation

2 weeks ago


Bengaluru, Karnataka, India Novo Nordisk Full time

Roles and Responsibilities:

As a Senior IT Validation & Compliance Expert at Novo Nordisk, you will serve as a Subject Matter Expert (SME) for Validation activities, executing the validation strategy both in Agile and V Model as necessary.

You will perform various assessments, including IT Risk Assessment (ITRA), IT Requirements Risk Assessment (ITRRA), quality, functional, data integrity, and supplier assessments.

In addition, you will participate in global forums to provide quality and process inputs and share knowledge within and outside the department.

As a compliance SME, you will provide trainings or share knowledge in global forums and offer compliance consulting for IT projects, delivering compliance deliverables with respect to CSV/CSA.

Qualifications:

  • MCA, M.Sc., B.SC., BE, or similar graduate degree in a relevant field.
  • Overall experience of more than 10+ years in the IT or equivalent industry.
  • Minimum 10+ years of experience in working in a pharmaceutical/service-based organization, preferably in the IT quality domain.
  • Minimum 5+ years of practical experience in GxP areas with exposure to regulatory requirements.
  • Minimum 5+ years in performing RCAs, CAPA, and any other relevant IT quality assurance activities.
  • Good understanding of GAMP 5 and various regulatory requirements, including CFR part 11, EU Annex 11.
  • Ability to represent NN in relations with users and external stakeholders.

About Novo Nordisk:

Novo Nordisk is a leading global healthcare company with a legacy of driving change to defeat serious chronic diseases.

We are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily.

Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world.

We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them.



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