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UDLØBET

Novo Nordisk

Senior GMP Expert

Fuldtid

Permanent

Brennum Park 20k, 3400 Hillerød, Danmark

SE PÅ KORT
ID: 2611216
|
Indrykket for 32 dage siden

Are you passionate about developing in-depth knowledge of GMP standards and fostering a quality mindset in Quality Control within QC for Clinical Production, Design Verification Test Lab, and Investigation Lab for Customer Complaints? Do you enjoy driving quality improvement initiatives and engaging with many stakeholders across a department in an ever-changing and growing environment, to discover the best solutions? If this sounds like your ideal position, then the Senior GMP Expert opportunity in Device Manufacturing Development (DMD), Product Control and Global Support will be the perfect fit for you!

The position

As a Senior GMP Expert in Product Control and Global Support, your role involves managing different quality related activities across the department. Occasionally also across DMD. The nature of these activities can vary, ranging from those closely tied to enhancing our local laboratory processes to those associated with more cross functional activities in our development processes of our Devices and Combination Products. Depending on the quality activity, you will take the lead in guiding team members of highly skilled technicians and Engineers in charge of developing and optimizing systems and processes. You will have a holistic and pragmatic view in ensuring a high level of quality and compliance within Product Control and Global Support. This will involve setting appropriate standards anchored in our Quality Management System (QMS), enabling us to meet all relevant GMP requirements and implementing efficient structures to prepare for future audits and inspections.

You will be focusing on:

  • Ensuring high-level GMP overview and report quality trends to management.
  • Supporting daily QC operations, identifying improvements, and ensuring continued compliance
  • Leading and coordinating root cause investigation activities of potential quality and compliance issues across both the department and the functional area.
  • Driving and implementing quality improvements across the department
  • Driving and participation in the preparation for and follow-up on authority inspections and internal audits.
  • Handling deviations, investigations, quality processes, advising department members on questions and challenges.
  • In this position, you will have a high level of independence, guiding and teaching the department, colleagues, and management.

    Qualifications

    To succeed in this role, we imagine you:

  • Hold a master’s degree in pharmacy, biochemistry, production engineering or similar with several years of experience in the pharmaceutical industry with GMP
  • A strong understanding of GMP regulations and requirements
  • Experience with investigations, Inspections, and deviations
  • Stakeholder management with experience in setting direction, guiding/coaching
  • Solid cLEAN mindset and experience in using cLEAN tools
  • Demonstrate professional proficiency in both spoken and written English.
  • On a personal level, you see yourself as being self-driven, independent, proactive and solution oriented. You are a strong communicator who works systematically and strive for simplicity. You enjoy collaboration, thrive building networks and working with individuals at all levels of the organisation.

    About the department

    You will be part of DMD, Product Control & Global Support, where we assist device development from the early R&D development stages into production for clinical trials and eventually into production to market. Reporting to the Senior Manager of Projects and Product Control Development, you will be a member of a diverse team of highly skilled professionals, Specialists and Project managers who also working across the department and the organisation.

    As a high-potential collaborator in our department, you will embrace significant responsibility and receive guidance to foster your personal and professional growth. You will work alongside positive and agile colleagues who will share their expertise to for future challenges. Our diverse team includes international colleagues with various backgrounds and experiences.

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