Senior QA CMO Professional
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Køge
Are you seeking a dynamic and challenging role in a growing company with exiting products? Are you looking for a place to feed your enthusiasm for quality? Do you want to make an impact for ensuring the right compliance level for new products in our pipeline both inhouse and for outsourced activities? Then read more and apply to become our new senior QA professional! The position As Senior QA professional you will play a pivotal role for us to succeed with our strategy for new products that enables better medicines for our customers. You will have two main responsibilities in our team: You are one out of three QA partners for our Research & Manufacturing Development (R&D). You will have a close cooperation with R&D about product and process development and tech transfer to either our intern Manufacturing or a Contract Manufacturing Organization (CMO). Together with our colleagues in R&D you select and assess CMOs. You take the lead ensuring the CMO Quality Management System (QMS) is sufficient to fulfil relevant GMP requirements. You are responsible for negotiation and implementation of quality agreements, approving validation strategy and related documents as well as setting up the QA processes for commercial manufacturing. You will also participate in qualification audits performed at the CMO and ensure sufficient follow up on CAPA’s. We offer an exciting and challenging position in an amazing department where focus on collaboration and team spirit are key. As a new member of the team, we will prioritize your training and support you in gaining the competencies needed.
Qualifications M.Sc within Science, Pharmacy, Chemistry, Biotechnology or similar 5+ years experience in the pharmaceutical industry either within QA, Product Development or Production Support Experience with CMO’s (Contract Manufacturing Organizations) and outsourcing Experience with technology transfer from development to commercial phase and/or as part of products from one site to another It is a big advantage if you have experience within aseptic production, quality agreements and/or raw materials and primary packaging On a personal level, you are a self-driven and strong team player with excellent problem-solving and communication skills; you are proactive and solution-oriented with a can-do attitude and strategic focus. Openness, honesty and focus on continuous improvements and quality mindset are natural parts of your personality and the way you work About the department Novo Nordisk Pharmatech A/S is a fully owned subsidiary of Novo Nordisk A/S situated in Køge. Novo Nordisk Pharmatech A/S is a leading global supplier of high-quality ingredients for the biopharmaceutical and pharmaceutical industries, supplying products such as recombinant insulin for cell growth media and pharmaceutical grade quaternary ammonium compounds as well as raw materials for Novo Nordisk A/S. The team is a part of the QA/RA department at Novo Nordisk Pharmatech A/S. QA/RA department currently consists of 20 employees working diligently to support the entire value chain, from Research & Development to Production and finally Sales & Marketing. We also cover quality and regulatory affairs related communication with the authorities, our B2B customers, our distributors, and our suppliers.
Working at Novo Nordisk Pharmatech Novo Nordisk Pharmatech A/S has approximately 300 employees and is 100% owned by Novo Nordisk A/S. The ability of Novo Nordisk Pharmatech A/S to produce and deliver quality products to the pharmaceutical industry, combined with our complete range of services within the regulatory requirements, makes us a preferred supplier to many global pharmaceutical companies. Novo Nordisk Pharmatech A/S is a growing company, which will provide many exciting projects in the future and good development opportunities in the job. Contact For further information, you can contact Senior Manager, Lene Berg Jørgensen, on +45 31 97 00 21.
Deadline
November 27, 2023 You do not need to attach a cover letter to your application, but please include a few sentences about your motivation in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. Do you know someone?
If it is not the job for you, but perhaps you know someone who might fit and be interested, please share this job. Thank you for your referral. 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.
Qualifications
Working at Novo Nordisk Pharmatech Novo Nordisk Pharmatech A/S has approximately 300 employees and is 100% owned by Novo Nordisk A/S. The ability of Novo Nordisk Pharmatech A/S to produce and deliver quality products to the pharmaceutical industry, combined with our complete range of services within the regulatory requirements, makes us a preferred supplier to many global pharmaceutical companies. Novo Nordisk Pharmatech A/S is a growing company, which will provide many exciting projects in the future and good development opportunities in the job. Contact For further information, you can contact Senior Manager, Lene Berg Jørgensen, on +45 31 97 00 21.
Deadline
November 27, 2023 You do not need to attach a cover letter to your application, but please include a few sentences about your motivation in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. Do you know someone?
If it is not the job for you, but perhaps you know someone who might fit and be interested, please share this job. Thank you for your referral. 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 Køge.
Jobbet er oprettet på vores service den 11.7.2023, 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
- Køge
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