Advanced QA Professional
2 days ago
Category:
Quality
Are you passionate about quality assurance and eager to take on a challenging role in the pharmaceutical industry? We are seeking an Advanced QA Professional to join our QA API (Active Pharmaceutical Ingredient) department in Copenhagen This role is crucial in ensuring the highest standards of quality and compliance within our organization.
Join a great team of dedicated professionals committed to making a difference. Apply today for a life-changing career
The Position
This role is located in our API production facility in Gentofte. Our primary responsibility involves establishing quality and compliance standards in line with both internal and external requirements. While reviewing validation documentation, batch documentation, trend reports, SOPs, deviations, and change requests, you will maintain a QA presence by being physically present in the production area. This allows for observing performed processes and helping to solve issues in real time.
Your key responsibilities will include:
- Provide QA approval for various tasks, including the preparation, review, and approval of records and documentation such as deviations, change requests, SOPs, and validation documentation.
- Review batch documentation and assign status to products from API.
- Oversee quality performance, identify trends, and participate in Quality Management Team (QMT) activities.
- Ensure real-time operations comply with written procedures, verify housekeeping, and proactively assess potential trends and logbooks.
In addition to the primary responsibilities, you will also assist in developing and implementing activities aimed at improving the general quality level in stakeholder departments and the QA organization. You will participate in inspections from health authorities as a presenter, QA representative, and note taker, and train colleagues in GMP tasks. You will have the opportunity to significantly impact decision-making, drive initiatives, and actively engage. We foster a positive working environment and encourage resolving challenges through open and honest dialogue.
Qualifications
We realize that few people are experts at everything. But if you can nod your head at the fol-lowing attributes, then you could be the person we are looking for:
- A Master’s degree in pharmacy or a related field.
- Some years of relevant experience in a GMP-regulated environment.
- Proficiency in Danish and English.
- Experience in QA is a plus, as well as production experience.
As a person, you contribute positively to a cohesive working environment and demonstrate strong collaboration skills with colleagues. You have a proven ability to engage in solution-focused dialogue with both production and other QA colleagues. Your stakeholder management skills are exceptional, allowing you to navigate complex interactions effectively. You are assertive and capable of saying no when necessary, ensuring compliance and quality stand-ards are maintained. Your proactive and communicative approach fosters a positive and productive atmosphere within the team.
About The Department
We are a well-functioning department with many interfaces in the organization including production, management, and other QA departments. We are 70 employees covering the production of API across our sites in Hillerød, Kalundborg and Gentofte. You will be part of the team with 10 great colleagues based in Gentofte.
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 worldwide. We value the unique skills and perspectives our peo-ple 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
For further information, please contact Adam Morris, QA Manager, at +45 3075 8222.
Deadline
9 February 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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