QA Specialist – close collaboration with the production

Bavarian Nordic A/S

Fuldtidsjob
Nordsjælland

QA Specialist – close collaboration with the production

Would you like to set high standards in Quality Assurance and help to support the quality oversight of Manufacturing and the review and release processes within production of vaccines to protect against Smallpox, Ebola, Respiratory Syncytial Virus and future cancer vaccines? Be in contact with many different departments at our production site in Kvistgård? Then this position as a QA Specialist is the position for you.

Newly established team
Our QA department is responsible for QA overview of the release flow, release of all raw material, batch review and approval, support incl. deviation handling to the production specifically on environmental monitoring at the site, SOP, protocol and report approval and ensuring that current pharmaceutical regulatory requirements, industry standards and Bavarian Nordic’s procedures are followed.

QA consists of 23 employees, including QPs, Specialists and Compliance officers. You will be a part of the newly established Review & Release team with 8 colleagues and be reporting to Manager, Review & Release.

The main task for the Review and Release team is to support and improve the daily operational tasks within review of Manufacturing, QC testing, Environmental Monitoring and Raw Material documentation.

Daily support and improvements
This position is with special focus on supporting the daily review and release flow from aseptic production within technologies like Formulation in single use technology, Isolator filling/freeze-drying, Inspection and Packaging including Serialization.

You will:

  • Provide quality support and review of batch records and relevant data in the production area
  • Provide general support and training within the Quality System and processes to Production and support departments
  • Review and approve SOPs, Change Requests, Deviations and CAPAs
  • Take active part in general QA activities for Bavarian Nordic projects

3 years of experience

  • You hold a relevant academic degree as a Biochemist, Microbiologist, Pharmacist or similar.
  • You have a minimum of 3 years of experience from a pharmaceutical/biotech organisation and has been working as QA for a GMP production
  • Preferably you have experience with and knowledge of GMP within areas like isolator technology/freeze-drying/packaging/serialization or advanced technologies
  • Preferably you have experience with QA Aseptic Oversight
  • You master fluent communication skills in Danish and English as our corporate language is English and the majority of documentation is written in English.

You are an open-minded person that can create a good relationship with stakeholders on all levels. You thrive in a setting where you have the possibility to influence ways of working and can contribute with your own ideas. You are a strong ambassador of a quality mind-set but also contain a pragmatic approach. Additionally we would enjoy having a straightforward person with a good sense of humour in our department.

We offer…
an exciting position in an international company with a unique technology and manufacturing process within vaccine/biologic production. You will be working in an open culture, where everybody is working in the same direction and where there is room for ideas and independent action.

Caught your interest?
If you are interested in the position, we look forward to receiving your application via our recruitment system as soon as possible. Just click the Apply-Button on the right side of the page and you will be redirected to our application form.

We are interviewing on an ongoing basis.

Further information
If you are missing some job details do not hesitate to contact Snr. Director, QA, Dorthe Kroun, on Mobile no. +45 2949 5060 or by e-mail: Dorthe.Kroun@bavarian-nordic.com.

Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases. The company has a diverse and growing portfolio of vaccines, supported by proprietary development, public-private partnerships and industry collaborations. The company was founded in 1994 and has been listed on the Nasdaq Copenhagen Stock Exchange since 1998. Headquartered in Kvistgaard, Denmark and with operations in Munich, Germany and North Carolina, USA, the company employs more than 400 people. Bavarian Nordic is an Equal Opportunity Employer.

www.bavarian-nordic.com

Join Bavarian Nordic and take a step into the future of vaccines. Our goal is to develop innovative and safe therapies against cancer and infectious diseases to improve the health and quality of life for children and adults.

Søg jobbet
Ansøgningsfrist: 11/08/2019

Mere om os

Del
Kontakt os
Dorthe Kroun

Director, QA

Dorthe.Kroun@bavarian-nordic.com

+45 2949 5060


Login for at se hele opslaget

Dette jobopslag er kun tilgængeligt for vores brugere. Log ind eller opret en profil - det er gratis og tager kun to minutter.

Log ind med sociale medier


Log ind med din karriereprofil

@


Glemt kode Ny bruger

Ansøgningsfrist d. 08.11.2019

Angiv venligst i din ansøgning, at du har set opslaget i Akademikernes Jobbank

Fuldtidsjob
Nordsjælland
Kemi, Biotek & Materialer
Medicinal & Sundhed
Produktion, Logistik & Transport
Data & analyse
Forskning & Udvikling
Medicinal & Sundhed
Produktion



Bavarian Nordic A/S - hurtigt overblik


Placering
Hejreskovvej 10A
3490 Kvistgård
Logo: Bavarian Nordic A/S
Efterspørgsel efter nye talenter

Hvilke jobtyper og arbejdsområder udbyder vi normalt og hvor mange nye talenter søger vi efter?


Webside

Få mere info omkring vores virksomhed på vores egne websider:

www.bavarian-nordic.com


Bavarian Nordic A/S i Google

Er der andre informationer om os, som du burde vide? Se, hvad en Google-søgning siger.



https://jobbank.dk/job/1350964/