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Novo Nordisk

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4.1

based on 930 Reviews

Proud winner of ABECA 2024 - AmbitionBox Employee Choice Awards

Top Rated Pharma Company - 2024

57 Novo Nordisk Jobs

IT Validation & Compliance Specialist I

Novo Nordisk Centre (India) Pvt Ltd

4.1

based on 930 Reviews

3-6 years

Bangalore / Bengaluru

1 vacancy

IT Validation & Compliance Specialist I

Novo Nordisk

posted 4hr ago

Job Role Insights

Flexible timing

Key skills for the job

Computer Networking IT Infrastructure DBMS Data Validation Server Management Gxp

Job Description

As an IT Validation Compliance Specialist I at Novo Nordisk, you will have the following responsibilities:

Participate in system releases, perform validation roles, and ensure that documentation and verification activities meet quality and compliance requirements as per the Quality Management System (QMS) and regulatory guidelines

Collaborate with the Quality Assurance team to fulfil overall quality assurance responsibilities

Ensure configuration documents are updated, participate in annual periodic reviews, and represent the system during internal and external audits

Manage audit preparation and representation, if required

Ensure all compliance deliverables meet specified requirements in content and form, approving them in accordance with defined standards

Understand system complexity from a quality and compliance perspective and support system operation and maintenance

Coordinate the validation process for system changes and releases, collaborating with Line of Business (LOB) and system management teams

Take ownership of associated documentation activities

Manage compliance and documentation for IT operations, changes, problems, and incidents that impact the system

Work closely with stakeholders to ensure adherence to standards, regulatory requirements, and GxP processes for change management and implementation

Qualifications

To be successful in this role, you should have:

Bachelors or masters degree in a relevant field with 10+ years of experience in IT or the pharmaceutical industry, including system management experience and a strong understanding of GxP systems

Should have a strong understanding of compliance and documented GxP experience across multiple systems, along with a solid background in validation and IT infrastructure, including expertise in databases, networking, and server management up to the OS level

Experience in ITIL processes with strong expertise in change management to assess the impact of system changes and provide validation support for PACS, including validation planning, documentation as per SOP, test case authoring, review, and approval

Should have knowledge of compliance activities, including design, development, testing/validation, documentation, implementation, and maintenance of IT solutions in large organizations

Must have experience managing medium-sized upgrade projects or similar initiatives

Experience working with agile delivery models and should have experience in performing Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), and other relevant IT quality assurance activities

Excellent interpersonal and communication skills including verbal and written communication

Ability to represent NN in relation with users and external stakeholders

Employment Type: Full Time, Permanent

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