QA for Quality Control - Microbiology

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Are you passionate about assuring high-quality products that make a difference in the lives of patients with chronic diseases? Do you thrive in a fast-paced environment with lots of opportunities to collaborate with stakeholders and colleagues? We are seeking a QA Specialist for Quality Control - Microbiology to join our dynamic and highly skilled QA department. This role is pivotal in ensuring the highest quality standards in our microbiology labs. Apply today for a life-changing career! The Position Our main goal is to ensure top-quality products for our patients. In QA for QC-Microbiology, we ensure compliance with guidelines to release analytical results. Our tasks include reviewing and approving various GMP documents for analytical methods and lab equipment. We conduct analyses such as Isolator, Autoclave, MALDI-TOF, and general pharmacopeia methods. Additionally, we aid in developing and validating microbial methods for new products in our pipeline, both in-house and at Contract Manufacturing Organizations. The team also supervises quality activities at our QC laboratories in Gentofte & Bagsværd. Your key responsibilities will include:
  • Manage Deviations (DVs) and Change Requests (CRs) and approve new test methods developed in the competence center.
  • Manage stakeholders to prioritize lab tasks and ensure close collaboration.
  • Maintain and update training documentation and SOPs to ensure products meet quality standards and compliance requirements, and coordinate trainings within the area.
    • You will undergo a structured and individual training program, and you can expect increasingly more responsibility. You will have an individual development plan to ensure continuous development and realization of your full potential. Equally important, we have a high focus on a great work-life balance, with the flexibility to work from the office and home. Qualifications We realize that few people are experts at everything. But if you can nod your head at the following attributes, then you could be the person we are looking for:
  • A Master's degree is preferred but can be compensated by long experience in the field.
  • Some years of experience in quality control (QC) and Good Manufacturing Practice (GMP) within the pharmaceutical industry.
  • Strong understanding of and interest in microbiology and its applications in the pharmaceutical industry.
  • Proficiency in English is required.
    • As a person, you have excellent stakeholder management skills and can prioritize lab activities effectively. You are independent, proactive, and detail-oriented, with a strong interest in microbiology. You excel in a collaborative environment and can build strong relationships with team members and stakeholders. You are comfortable working in a high-paced environment and can prioritize tasks. . About the Department You will join a team in a highly dynamic, newly established department in Aseptic Manufacturing QA with many interfaces and stakeholders around the organization. Our team supports and oversees quality activities at our QC laboratories, ensuring the highest standards of quality and compliance in all processes. The department has a high level of self-governance, and the working relations are informal. We value good humor and an open and honest culture. We appreciate a colleague who takes responsibility, has a positive and curious approach to new challenges and contributes to a pleasant working atmosphere. Working at Novo Nordisk Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. Our success relies on the collaboration of our more than 63,000 employees around the world. We value the unique skills and perspectives our people bring and continuously work to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves. Join us! Together, we go further. Together, we're life-changing. Contact If you want to know more about the position, please contact QA Manager, Misbah Malik at +[xxxxx]. Deadline 29 January 2025. Applications will be processed as they are received, so do not hesitate to apply. 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 to 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.


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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Bagsværd.

    Jobbet er oprettet på vores service den 16.1.2025, men kan have været deaktiveret og genaktiveret igen.

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