Senior Quality Professional II

3 weeks ago

Bengaluru, India Novo Nordisk AS Full time

Department: R&D Quality GBS, Novo Nordisk Quality GBS

Are you passionate about ensuring high-quality processes and products? Do you have experience in quality assurance and regulatory compliance? We are looking for an Senior Quality Professional II - Master Data to join our R&D Quality team at Novo Nordisk. If you are ready for a challenging and rewarding career, read on and apply today for a life-changing opportunity.

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.

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