Senior Quality Professional II

1 week ago

Bengaluru, Karnataka, India Novo Nordisk Full time
The position
As an Senior Quality Professional II
  • Master Data, you will have the following responsibilities: Master Data Approval and Coordination: Take a key role in the approval process of Master Data and Engineering Change Orders (ECO) in SAP and Winshuttle systems for all NN products.
Ensure accuracy and completeness of data.

Master Data Quality Assurance:
Plan, coordinate, and execute Quality Assurance (QA) tasks related to Master Data as necessary. This involves ensuring data integrity, consistency, and compliance with regulatory requirements.

Regulatory Compliance Support:
Provide Quality Assurance services specifically tailored for Regulatory Affairs and other pertinent areas within client master data. This includes ensuring adherence to regulatory standards and guidelines.

Global Labelling Quality Assurance:
Oversee quality assurance for global labelling across all NN products. Support or participate in core process groups dedicated to labelling. Ensure labelling compliance and accuracy.

Training, Audits, and Process Improvement:
Provide on-the-job training to colleagues and serve as a mentor or buddy for new hires when necessary. Participate in audits and inspections, contributing to continuous improvement initiatives. Additionally, actively engage in relevant cross-functional quality projects to enhance overall processes and outcomes.

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

The candidate should hold a graduate or post-graduate degree in Science or possess a comparable qualification relevant to the pharmaceutical industry.

Demonstrates 7-10 years of overall work experience within the pharmaceutical sector, with a minimum of 3-5 years focused on SAP systems Proficient in PP-PI (Production Planning
  • Process Industry) and MM (Material Master) modules, with expertise in managing processes such as printed packaging material approvals, BOM approval, MM approval, Batch release, and ECM approvals.
Proficient in PC-tools with extensive knowledge of MS Office suite.

Exhibits excellent presentation skills and possesses advanced knowledge of MS Office, including the ability to analyze data sets and advanced Excel skills.

Familiarity with quality processes and tools such as Deviation Management, Change Request (CR), Quality Assurance Plan (QAP), Quality Management Review (QMR), and Standard Operating Procedures (SOPs).

Capable of managing cross-functional project groups across borders and cultures, facilitating effective communication and collaboration.

About the department You will be joining our R&D Quality team, which is part of the Development Organization at Novo Nordisk.

Our team plays a vital role in supporting the drug and device development process, ensuring high quality and fit-for-purpose processes throughout the entire value chain.

We provide quality and compliance support to various areas within the organization, including Regulatory Affairs, Global Safety, Clinical Reporting GBS, and Clinical Data Sciences GBS.

Working in a global setting, we focus on delivering viable products that make a difference to patients and ultimately benefit society.

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

Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily.

All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63, 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.

Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us Together, we go further. Together, we're life changing.

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