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QA Specialist Assembly
2 months ago
QA Specialist Assembly & Packaging or Tablets
Category: Quality
Location: Søborg, Capital Region of Denmark, DK
Join Global Contract Manufacturing (GCM) – Drug Product (DP) QA and contribute with tablets, assembly, packaging and compliance specialist experience.
Our team supports CMO assessments, operation support and transfer projects to CMOs in Europe, the US, and Asia.
Our organisation is expanding so we can continue to support the strong volume growth with capacity expansions at CMOs, a growing R&D pipeline progressing towards markets with CMO supply chains and acquired companies with fully outsourced CMO supply chains.
At the moment, the workplace is in Søborg but at the end of 2024 we will be relocated to Høje Taastrup.
The position
Do you want to make a real impact on the lives of patients with chronic diseases?
As a QA Specialist in assembly and packaging or tablets you will act as GMP adviser and mentor for QA colleagues in QA DP operation and transfer projects for outsourced production.
You will play a pivotal role in the selection and assessment of CMOs including negotiation and implementation of Quality Agreements.
Your extensive QA and GMP knowledge will be leveraged to ensure product quality and compliance with cGMP and marketing authorizations.
Your main responsibilities will be to:
- Provide GMP direction to QA colleagues, outsourced production
- Support the implementation of new quality compliance measures in close collaboration with management.
- Facilitate critical cases in collaboration with Line of Business and Global Contract Manufacturing (GCM) QA colleagues.
- Knowledgeable in requirements with assembly and packaging or tablets
- Provide training for QA colleagues.
- Participate in compliance discussions with Qualified Person (QP), QA Manager and CMO QA management.
- Drive internal compliance projects to ensure standards for outsourced activities.
- Be part of selection- and assessment process of potential new CMOs.
Furthermore, you will contribute to working groups, and projects related to QMS or your core area of expertise, serving as a subject matter expert in GMP and quality matters and by delivering training in quality activities.
The role requires up to 20-30 days of travel per year to primarily CMOs locations outside of Denmark. If you’re seeking a role that will challenge and develop your professional and personal competences, this is the opportunity for you.
Qualifications
To succeed in this role, you:
- Hold a master’s degree in Pharmacy, Chemistry, Engineering or similar
- Have strong pharmaceutical industry knowledge and understanding (8+ years of experience)
- Have significant Quality Assurance experience
- Have significant Finished product (FP) experience - preferable acquired in Production/QA working with FP processes in assembly and packaging lines covering validation.
- Preferably have experience with suppliers in a global environment, tech transfer and commercial manufacture.
Expertise in quality requirement for contract manufactured products and experience with outsourcing will be seen as an advantage.
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. Finally, your excellent communication skills allow you to engage at all levels of the organization and make independent decisions.
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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