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Project Manager & QA Specialist, MFG Documentation

AGC Biologics



Copenhagen, Denmark

Do you have an urge to color coordinate the magnets on the lunchroom’s whiteboard? Are you having small contractions around your eyes when a colleague is wearing their lab coat inside out? And have your surroundings realized the need for clear structural processes after listening to your heavy breaths and many corrections?
Okay, you don’t have to be Rain Man to fill the position as our new Project Manager & QA Specialist – but kind of. At AGC Biologics we are looking for you who understands the importance of structured processes and have experience in working with quality assurance. And of course, someone who wants to be part of a team with the mission to improve patients’ lives.

Are you ready to be our frontliner QA Specialist?
You will be part of our department for manufacturing where you will design our ‘how to’ for the future – are you still following? We are expanding our AGC family and have grown out of our ‘this if how we’ve always done it’. Now we need you who knows more than most about quality assurance and documentation as we prepare for our continuous expansion.

Your responsibilities will be to:

  • Develop, implement and secure the use of standardized operational documentation within the manufacturing department.
  • Support inspections and audits and secure closure and follow up from observations.
  • Support the establishment of a dedicated team who understands and follows our processes.

Your out-going personality makes the difference
As you will oversee the implementation of our ‘new normal’ regarding documentation and processes it is important that you have great social skills. Getting to know your colleagues and discuss work-related tasks and issues is what motivates you. You listen, you evaluate, and you rarely accept the first ‘no’ you get.

You thrive in a fast-paced environment, and you interact fluently in English, both in writing and verbally.

The fairytale profile we are dreaming of
We hope you have a few years' experience working in the manufacturing industry – which gives you a clear idea of where to start and where we are going. Can you combine your manufacturing skills with experience in quality assurance - we've already come a long way.

Preferably you hold a relevant engineering degree, but we are open to see how we will be a match. Experience with change management (Lean), audits and inspections and digitalization of batch records will be a huge advantage.

Which expectaions can we fulfil?
‘With great responsibility comes great power’ - yes, we got inspired by Uncle Ben here, but that doesn’t make it any less true. You will be in charge of shaping the new tomorrow of AGC Biologics. Your ideas, your experience and your skills are valued, and we are ambitious – also on your behalf.

And don’t worry, you will not be on your own. You will have a team of dedicated collages who will share their knowledge, help and answer all the questions you might have. We might go at a high speed – but we make sure everyone is safely strapped in and ready for the ride.

Have you already pulled out your colour coordinated pencils?
Don’t hesitate to send us your application and CV. We will process the applications as they arrive.

Want to keep posted about our growth and to learn more about our company?

We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !

AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.

This job posting is collected from company pages and is only shown as short resume. Read entire job ad here:

view full ad at AGC Biologics



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Job type
Full-time job
Placement
Greater Copenhagen
Education
IT
Machine & Technical Design
Production, Logistics & Transport
Strategy, Org. & Leadership
Technology
Work area
Data & Analytics
Management & Planning
Medico & Health Services
Production
Project Management
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AGC Biologics at a glance


AGC Biologics
AGC Biologics
AGC Biologics offers deep industry expertise and uniquely customized services for the scale-up and cGMP manufacture of protein-based therapeutics, from pre-clinical to commercial production, using mammalian and microbial production systems.

Geography
Vandtaarnsvej 83B
2860 Søborg
Logo: AGC Biologics
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