GMP Coordinator for production support
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Kalundborg
Are you motivated by being a part of a pharmaceutical production of finished products in aseptic fill, and by setting standards for Quality and GMP? Do you have a detail orientated approach and competences to communicate clearly? Are you self-motivated, structured and have an efficient nature, and do you have the ability to see solutions in a broader perspective? Then you are the candidate that we are looking for! The Position As our new GMP Coordinator you will be working to ensure a high level of quality and compliance in our aseptic production in Novo Nordisk by setting standards and maintaining and updating the Quality Management System (QMS), through ensuring that the production continuously deliver on the GMP rules by keeping and adjusting their GMP mindset. This by keeping our focus on Operational Excellence, and by zooming in on continuous improvements of our processes. You will, as mentioned, be working closely with colleges within the department but also across departments including QA of our production unit and be r esponsible for: Driving preparation for and follow-up on authority inspections and internal inspections together with the GMP group Supporting daily operation with quality and ensuring high level of GMP on shopfloor Participating in department projects. Supporting GMP in department deviations and change requests Interpret existing and new GMP rules for implementation in the department Training of new employees in GMP Furthermore, you will be performing trend reports for the QMR, QMT’s, own deviation (including CAPA’s), and risk assessments, whilst changing requests and SOP’s. Qualifications To succeed in this role, you will have: An academic degree in pharma, engineering or similar Solid experience with GMP, compliance and documentation Excellent interpersonal skills and proven experience in working with stakeholders at all levels Manifest Excel and complex data competencies Full professional proficiency in English and the ability to communicate in Danish. On a personal level, you thrive and get motivated by working with and across all levels in the organization whilst you are known for your excellent collaboration skills and ability to set direction when it is needed. You are solution orientated, and you work systematically, logically, and proactively, so you take initiatives on your own and you take pride in solving your tasks and challenges as close to the process as possible, with close involvement of your key stakeholders. About the Department Our team is part of the BRD Finished Products Kalundborg area that is part of our largest production complex in Novo Nordisk. Here we are app. 520 colleagues who take responsibility for transforming Active Pharmaceutical Ingredients into the finished product that patients can use all over the world. We rely on our stabile/well-run/best-in-class packaging department and our newly established high-tech and high-volume filling facility. Our complex processes require a high level of expertise, commitment, and engagement from our employees and include formulation, filling, freeze-drying, product inspection, assembly, and pack. We bring value to patients by delivering high-quality Good Manufacturing Process (GMP) compliant products in a timely and cost-efficient manner. We drive change by working actively with LEAN and always looking for improvements within our processes but also in the way we work together to make our products reach as many patients as possible. Working at BRD, Novo Nordisk Biotech & Rare Disease (BRD) is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and in quality production of pharmaceutical products. In BRD we are not only supplying all Novo Nordisk products for Rare Diseases, but also using our competences in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are app. 2650 colleagues committed to drive change for people with serious chronic diseases. We produce our life-saving medicines out of five state-of-the-art production sites in Denmark and United States - covering the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. Not only are we making a difference for patients – we are also stiving to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone. Are you ready for a life-changing career? Contact For further information, please contact Senior Director, Anders Bekker-Jeppesen +45 3075 0790 Deadline 20 August 2023. Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV 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.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Kalundborg.
Jobbet er oprettet på vores service den 27.3.2023, 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.
- Øvrige
- Kalundborg
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