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Advanced Business Analyst

3 months ago

Bengaluru, India Novo Nordisk AS Full time

Department: Digital Quality- NNQ GBS

Are you passionate about ensuring quality and compliance in the pharmaceutical industry? Do you excel at leading validation efforts to guarantee regulatory adherence? If so, we want you to join our dynamic team as Validation Lead, read on and apply today for a life-changing career
 

The position

As our Validation Lead, you will utilizing your extensive GxP experience ensure that the digital solutions we develop, systems/ processes meet and exceed regulatory standards. You will collaborate cross-functionally with different Line of Business across the organization to develop and execute validation strategies, protocols and reports.

Key responsibilities-

Lead validation activities for processes, systems, applications/digital solutions (CSV) in accordance with GxP regulations. Develop and execute validation plans, protocols, and reports, risk-based validation strategy, ensuring compliance with regulatory requirements. Provide guidance and expertise on validation best practices and regulatory standards. Performing compliance-related tasks including system documentation, review, and approval of CSV deliverables. Collaborate with cross-functional teams to integrate validation activities into the product development lifecycle. Participate in audits and inspections related to the project supported, including finding solutions to compliance gaps identified. Act as a liaison between Quality Assurance and system management to ensure system compliance requirements. Participate in system releases as a Validation SME. Drive continuous improvement initiatives to enhance validation processes and efficiency.

Qualifications

To be successful in this role, we are looking for candidates with the following qualifications:

Bachelor’s or master’s degree (MCA, M.Sc., B.Sc., or similar) in Computer Science, IT Quality, or a relevant field. Industry-recognized certifications in ITIL and ISO quality management are preferred. Minimum 8+ years of experience in QA validation, with at least 5+ years of practical experience in GxP areas and 4+ years in performing CAPA, Change requests, and other relevant IT quality assurance activities. Excellent knowledge on regulatory requirements (cGMP etc) as well as internal requirements. Broad knowledge of basic IT technologies to be able to understand, and challenge decisions made by IT QA. Very good understanding of GDP & GAMP 5 standards. Detailed oriented mindset with a focus on quality and compliance. Proven track records of leading successful validation projects. Excellent communication and interpersonal skills with ability to collaborate effectively cross geographies/teams.

Join us in our mission to deliver high-quality compliant products that improve patient outcomes

About the department

NN Quality GBS Unit- Our purpose is to make “Quality” simple, easy and understandable. Digital Quality team is one of the departments under NN Quality GBS, which is an extended team of Denmark. We in Digtial Quality- lead the digital transformation and drive digital innovation in NNQuality by providing a clear guidance on digitalization from a Q perspective and removing barriers towards digitalization. As a member of our unit, you will be part of an ambitious and dynamic group of over 100 employees who ensures “highest quality to patients”.