Experienced Quality Management System (QMS) Partner for CMC Oral Protein Formulation (OPF)
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Are you passionate about compliance and quality, and do you see yourself as a main driver to ensure the right level of quality? Are you eager to join an area working with processes and technologies on the edge of the future? If yes, you are the QMS Partner we are looking for.
About the department
As part of Novo Nordisk’s R&D family, Chemistry, Manufacturing and Control (CMC) Development makes a real difference for patients with chronic diseases across the world. We develop and formulate all new protein and peptide processes coming out of our research units in our pilot plants, ensuring that we bring best-in-class treatments to the market. The Oral Protein Formulation (OPF) is an area within CMC Development, which employs approximately 160 highly skilled people organised in four departments and is based in Måløv. Our focus is to develop and manufacture solid dose tablets for pre-clinical and clinical trial phases I and II covering a broad and exciting range of process technologies for solid dosage forms.You will join the department - OPF Technical support – which consists of two teams, contributing with a broad range of skills, such as maintenance, calibration, qualification, IT, quality, training and general support to ensure daily operations. You will be a part of our IT & Quality team, consisting of 11 dedicated colleagues, with a broad range of skills, all contributing to sustain our “License to operate”, and we are currently expanding due to increased activity.
The position
We can offer an exciting position with a wide range of tasks and many different stakeholders. Overall, you will play a key role in setting direction within quality for the area, ensuring that compliance is maintained. Focus is to identify possibilities for improvements across our pilot plant (GMP), drug product development and analytical development that can cut out complexity and/or build quality into our processes.To drive this role, you are expected to be proactive in your engagement with your colleagues to understand how our business evolves and where potential challenges occur as well as actively work on improvements across departments. You will support your colleagues to ensure that we set the right quality standard within our facility, equipment, GMP Production and analytical procedures. In addition, you will be responsible for standardisation, optimisation and simplification of quality processes. Other key deliveries are helping with quality oversight tools, performing Quality Management Review and preparation and execution of internal audits and external Inspections.
As you grow in your role, you will become able to apply your quality mindset throughout our internal value chain. Being part of a quality sub-group within our team - which contain an QMS- partner, responsible, assistant/training coordinator and a training responsible - requires a structured approach in planning tasks and even more, an ability to collaborate, making sure that tasks is being executed, and stakeholders are informed in time.You will play a key role in our business-critical efforts to ensure and maintain the facility’s license to operate and our areas ability to develop future solid dosage forms. A strategic mind-set is a prerequisite, to assure we have the right set-up accommodating our plans going forward. Furthermore, you will assist in cross-functional improvement projects and participate in CMC QMS Process Group.
Qualifications
You:
- have a Bachelor’s or Master degree within Engineering or Pharmacy
- have minimum 5 years of experience from a pharmaceutical production company working with GMP Preferably you are knowledgeable also within the analytical field.
- have experience with some of the following processes and preferably with most of them; Deviation Handling, Change requests, Qualification and validation, Environmental Monitoring or Quality Control.
- are proficient in written as well as spoken Danish and English
On a personal level, you:
- are a good communicator, who shares knowledge to strengthen the overall quality mindset in our area.
- show high level of commitment to find constructive solutions to challenges and the ability to act as a role model in setting the direction in regards to Quality and Compliance issues
- If you bring a good portion of can-do attitude and humour, we will offer a safe environment, where you can further develop your skills.
- dare to take the lead, even when the task initially is a bit blurry.
- have a good approach to structure, when it comes to planning and execution of tasks.
We look forward to welcome you in our team, and in OPF.
Contact
For further information, please contact Senior Manager, Kenneth Aalbæk Jensen at +45 30753501.
Deadline
24th of November 2020.
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronic diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Bagsværd.
Jobbet er oprettet på vores service den 17.11.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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