Novo Nordisk

Senior Equipment Quality Control Professional

Fuldtid

Permanent

Gladsaxe

SE PÅ KORT

ID: 2600954

Indrykket for 13 dage siden

Are you passionate and experienced working with QC laboratory equipment ? Are you interested in metrology, qualification, and maintenance of analytical equipment and wish to upgrade our laboratory with automated procedures and tools for the future?

If so, you could be our new Senior Equipment Quality Control Professional in Microbiological Quality Control department located in Bagsværd. Read on to find out more and apply today and join us for a life-changing career!

The position
You will be part of the Equipment Team where you will be responsible for securing compliance so that the department’s machinery sees minimum down-time. Our equipment consists primarily of isolators, autoclaves, Matrix Assisted Laser Desorption/Ionization- T ime-of-Flight (MALDI-TOF), LAL readers, utensil washers, incubators, microscopes, pH-meter, balances, pipettes, refrigerators, freezers, temperature monitoring system (FMS), etc.

Your primary tasks will include:

High-quality support to analytical teams, ensuring they can conduct the analysis necessary to release our finished products in time.

Approval of the required documentation of both planned and unplanned maintenance of analytical equipment

Setting and maintaining calibration requirements, handling deviations, change requests, and qualification approvals.

Contributing to ongoing optimisation of our existing processes with being curious about how other teams and departments operate, both inside and outside of Novo Nordisk

In Novo Nordisk we are on a journey of digitalizing our QC laboratories by e.g., introducing automated processes and connecting laboratory equipment to Laboratory Information Management System (LIMS) to support a paperless future. You will have the opportunity to contribute to this journey by being observant about new, innovative solutions and secure successful implementation.

The position will be based in Bagsværd, Denmark.

Qualifications

To succeed in this role, you have:

A MSc degree in Sciences, Engineering, Biotechnology, Pharma or similar

Preferably with 5+ years of experience from a QC function in the pharmaceutical industry or other highly regulated industries

Knowledge about the criteria for maintaining analytical equipment and GMP equipment qualification.

Experience in setting and maintaining calibration criteria while working with metrology is advantageous, as well as change request, deviation, and technical writing experience.

As a professional, you are self-motivated and never afraid to take initiative or to take on responsibilities. You are a strong communicator; you find it natural to establish new relationships and are known for your good collaboration skills. It is second nature for you to comply with deadlines, have a systematic approach to problem solving and possess flair for processing data. You are eager to learn and are energized by communicating with your colleagues and stakeholders.

About the department
Injectable Finished Products (IFP) Quality Control (QC) Microbiology is part of IFP Manufacturing Development. The department is located in Bagsværd and consists of 60 employees divided into 4 teams. Our department has the overall responsibility for the microbiological analysis of finished insulin products and water samples coming from production. We are receiving samples from our world-wide production sites.

Analysis performed in the department includes environmental monitoring (EM), Test For Sterility (TFS), Bacterial Endotoxin Testing (LAL) and Total Viable Count (TVC). Our daily operations involve close dialogues with our closest stakeholders in other QC laboratories, Quality Assurance and the vendors.

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