Local Manufacturing Quality Advisor

2 months ago

Bengaluru, India Novo Nordisk Full time

**Department - **Local Manufacturing QA

**The Position**

As a Local Manufacturing QA, you will ensure daily batch release as well as contribute to Deviation, Change Control handling and QA oversight activities for LM Contract Manufacturing Organizations (CMOs). The holder of the position shall in collaboration with LM-QA in Denmark and the Site CMO QA to ensure that Novo Nordisk insulin products produced at LM CMOs are in compliance with requirements in Novo Nordisk specifications, quality agreements and local requirements. In this perspective you will be acting on behalf of the LM-QA Senior Manager. Furthermore, you will ensure faster response-time between Novo Nordisk and LM CMOs as well as creating a productive working climate. You are entrusted to fulfil the following responsibilities:

- Review and approval of batch records and status assignment of finished products for market.
- Support deviations and change request in collaboration with LM QA colleagues. For deviations where responsible QA, ensure deviations are adequately investigated and solved to root cause, and that the link between corrective actions is clear.
- Ensure effective contact to LM QA-DK, LM Site CMO QA and LM, support timeliness in general and ensure local CMO QMS and NN Quality agreement are followed
- Perform and report ongoing quality and compliance monitoring of CMOs including trending monitoring as part of QA oversight as well as for input to topics to be highlighted at the yearly QRM and together with LM/LM QA colleagues initiate counter measures when needed.
- The report must document tasks that are reviewed or observed and describe the general impression of the reviewed documentation or processes.

**Qualifications**
- Speaking and writing English without difficulties.
- Overall, 4 to 6 years of experience working in a Global Pharmaceutical Company.
- Work experience from the pharmaceutical industry.
- Hands on experience in end-to-end handling of Deviations and Change control.
- Trained and worked according to international validation principles.
- Experience with Change Request handling.
- Experience with GMP/GDP on operational level.
- Intercultural experience.
- Good interpersonal skills and Professional authority.
- Good communication skills in talking to people at all levels of the organization.

**About the department**

Novo Nordisk Quality GBS was established in May 2015. We are responsible for supporting and development of overall quality services, such as training coordination, content control, digital solutions, quality and compliance management and records management for various units within Novo Nordisk. Here, you will be a part of an ambitious, dynamic and global team consisting of over 100+ employees who ensure high quality as well as fit-for-purpose processes for the entire value chain from research to market. We make quality easy, simple and understandable.

**Working at Novo Nordisk**

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

**Contact**

**Deadline**

25th July 2023.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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