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Associate for Finished Goods QA Operations

FUJIFILM Diosynth Biotechnologies Holdings Denmark ApS

Hillerød, Nordsjælland

Indrykket
22-05-2020
Kontakt
FUJIFILM Diosynth Biotechnologies Holdings Denmark ApS
Biogen Idec Alle 1
3400
Hillerød
Praktisk information
Oprettet
22-05-2020
Udløber
15-06-2020
Kviknummer
330273421
Jobtype
Fuldtid
Arbejdsområde
Administration
Stillingsbetegnelse
Kvalitetsmedarbejder
Erfaringer - I højere grad
Ikke angivet (Økonomi), Ikke angivet (Kontor og administration), Ikke angivet (Jura og retsvæsen), Ikke angivet (Human Resources), Ikke angivet (Forsvar, politi, sikkerhed)
Sprog
Dansk Læse/ tale

Did you recently graduate with a Degree in Pharmacy, Chemistry or similar, and would you like to start your career in Quality Assurance? As a QA Associate in the Finished Goods (FG) Qualified Persons (QP) team you will have a good opportunity to get introduced to working in a QA organization and get familiar working in a Biopharmaceutical Contract Development & Manufacturing Organisation (CDMO).

About the job

FG QP Services at Fujifilm Diosynth Biotechnologies in Hillerød is a team of approx. 10 motivated professionals who manage review and release of both clinical and commercial products on behalf of our Partners. The team consist exclusively of Qualified Persons (authorized to perform batch certifications) who perform disposition of primarily Finished Goods (FG) to EU countries but also Rest of the World. We are part of The Finished Goods QA operations department with around 30 employees.

As a QA associate in the QP services team you will support the team with activities related to their daily operations. You will work closely with the team and also in collaboration with other QA teams in the FG QA operations organization. Working areas are expected to expand during your development in the activities you will be trained in.

Your main working areas will be to:

  • Electronic Archiving of Batch Records and Disposition Documentation
  • Sharing Disposition Documentation with Partners (electronic upload of documents)
  • Support the teams’ work with quality improve elements and other quality challenges in close collaboration with internal collaborators.
  • Support the team in batch record review related tasks.
  • Participate in departmental related projects.
  • Support the development and maintenance of the Quality Management System, including revisions of procedures (SOPs) and forms.

Professional qualifications:

You have recently finalized a degree as e.g. M.Sc. Pharmacy, Biology or Chemistry and have preferably gained some years of working experience in Manufacturing, Quality Control or Quality Assurance.

  • Master Degree in Pharmacy or similar education
  • Experience within production, QC, QA or delegated QP from the pharmaceutical industry preferred
  • Knowledge of GMP (EMA and FDA regulations) – label & packaging understanding preferred.
  • Strong communication and fluent English skills (written and spoken)

Personal Profile:

  • You bring a sense of humor and energy to work every day
  • You thrive in an international, multi-cultural environment, where things are constantly changing.
  • You have a positive and pragmatic attitude with focus on delivery on time
  • You are self-driven, positive and proactive, and you are able to take ownership and responsibility for your assignments
  • You create good working relationships with your colleagues; you are a strong team player

Please upload your CV and cover letter as soon as possible as we will invite candidates on a continuous basis. The job advertisement will be removed when the right candidate has been identified.

FUJIFILM Diosynth Biotechnologies is a world leading cGMP Contract Development and
Manufacturing Organisation (CDMO) with over 25 years’ experience. As a world leading CDMO we combine technical leadership in cell culture, microbial fermentation and gene therapies with state of the art GMP manufacturing, from our network of four global locations in the USA, UK and DK. We currently employ over 2,000 dedicated staff who have a reputation for excellent customer service, flexibility and responsiveness.

As part of FUJIFILM Diosynth Biotechnologies you will be an active contributor in the advancement of tomorrow’s medicine. We take pride in enriching our communities, caring for our environment and cultivating a world of opportunity for future generations. We invest in you and what you care about, getting the right work-life balance for your health, your family and your professional growth.

FUJIFILM Diosynth Biotechnologies offers a healthy work environment that promotes
individual responsibility, allowing you to grow and progress. We support our employees with
programs that motivate and educate, promoting a healthy work-life balance that ultimately
increases personal well-being and employee satisfaction.

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Job i virksomheden

FUJIFILM Diosynth Biotechnologies Holdings Denmark ApS

FUJIFILM Diosynth Biotechnologies Holdings Denmark ApS
Virksomhedsinformation
FUJIFILM Diosynth Biotechnologies Holdings Denmark ApS
Biogen Idec Alle 1
3400
Hillerød
Praktisk information
Oprettet
22-05-2020
Udløber
15-06-2020
Kviknummer
330273421
Jobtype
Fuldtid
Arbejdsområde
Administration
Stillingsbetegnelse
Kvalitetsmedarbejder
Erfaringer - I højere grad
Ikke angivet (Økonomi), Ikke angivet (Kontor og administration), Ikke angivet (Jura og retsvæsen), Ikke angivet (Human Resources), Ikke angivet (Forsvar, politi, sikkerhed)
Sprog
Dansk Læse/ tale
Beliggenhed
Gem annonce