Experienced QC Professional

7 days ago

Køge, Denmark Novo Nordisk Full time

The position

As an experienced QC Professional, you will work in close collaboration with the QC chemists and technicians and ensure that the analytical performance and equipment live up to industry standards, GMP and regulatory requirements (ICH guidelines, pharmacopeia, etc.)Your responsibilities will include:• Product responsible. Ensure understanding of the relationship between product and the QC analyses• Continuously improve and optimize our processes• Qualify, validate, and implement respective analytical equipment and analysis methods• Participate in projects and collaborate with stakeholders across the organization• Approve analytical results and secure their timely delivery• Participate in and facilitate systematic problem solving (SPS)• Assist in the preparation of documentation for customers and authorities• Present documentation during inspections and audits As we work under GMP requirements, Change Requests, SOP updates, deviations including OOS handling etc. are a natural part of the job. Qualifications To succeed in this role, ideally you will have:• A scientific academic degree such as cand. pharm., cand. scient., chemical engineer or similar; a Ph.D. in a relevant area could be an advantage• Experience from a GMP-regulated laboratory• Working experience as an analytical chemist with techniques such as HPLC, GC, titration and Spectrophotometer. Experience with analysis of enzymes is an advantage.• Relevant LEAN experience from a comparable position or education, combined with a natural eye for upscaling work processes and reduce waste• Strong communication skills and professionally proficient in both written and spoken Danish and English It will be considered an advantage if you have scientific experience within analytical development, impurity profiles and validation of method and quality risk management. On a personal level, you are a team player who is solution-orientated and have a positive attitude. As a person, you are analytical and at the same time keep an eye on the bigger picture. You thrive in an open and dynamic environment with a high degree of contact with colleagues both inside and outside the team. You grasp the importance of meeting deadline and thrive in doing so. Embracing change and proactively bringing forward new solutions, processes, and improvements are key qualities we are looking for in the ideal candidate. Moreover, you are comfortable in a dynamic environment where priorities shift rapidly. A sense of humour and a drive for success is highly valued in our team culture. About the department We are a well-functioning department, and you will be joining a team of 10 highly professional and motivated chemists, lab technicians, and an Analytical Coordinator who support the development of products and production with high-quality assays. The team also handles tasks like stability tests, raw material controls, input to regulatory documentation, implementation of new analytical equipment and software, CMO collaboration, development, and validation of methods etc. It is a laboratory with high complexity as we have many different analytical techniques.The laboratory is moving towards more digitalisation and use of data analyses, and we are in the process of replacing our current Laboratory Information Management System (LIMS) solution. Working at Novo Nordisk Novo Nordisk Pharmatech A/S (NNPR) is in Køge, Denmark, and is % owned by Novo Nordisk. The company has close to employees and the core task of the business is to enable better medicines through biopharmaceutical manufacturing for Novo Nordisk as well as for the global industry. NNPR is in the coming years expanding an already wide product portfolio within Enzymes, Synthetic Molecules, and Resins. The company has the full value chain with both R&D laboratories, production facilities, and a commercial organisation, plus a wide range of support departments on top.

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