Specialist* QA GMP Compliance & Master Records

  • Mainz
  • Work experience
  • Quality Management, Quality Assurance
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Become a member of the BioNTech Family!

As a part of our team of more than 2.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Specialist* QA GMP Compliance & Master Records

As Specialist* QA GMP Compliance & Master Records, you ensure that master records, validation records, etc. are well-documented, reviewed and approved by QA, which includes high quality batch records. Furthermore, this position supports overall GMP compliance through Quality Assurance support of the site.

Your main responsibilities are:
  • Contribute that controlled documents are well-documented, reviewed, and approved by QA, which includes batch records of diverse projects and manufacturing steps
  • Support the design and review of quality processes, documents and templates used for the review and release of GMP products
  • Support self-inspections and routine checks
  • Follow-up with Key Quality Metrices (KPIs) and training on GMP-compliance as required

What you have to offer.

  • University degree in Pharmacy, Biology, Chemistry, or a similar discipline 
  • Professional experience in the pharmaceutical industry (e.g. in quality assurance, pharmaceutical production, quality control) and within the GMP environment
  • Deep expertise and practical experience within Operational Quality Assurance
  • Profound knowledge of relevant US & EU regulations, EMA, FDA and other regulatory standards as well as Good Manufacturing Practice
  • High team spirit, excellent collaborating skills, and effective stakeholder management skills
  • High carefulness and accuracy in the way of working, conscientiousness and detail-orientation
  • Great communication skills and fluency in English and German

Benefits for you.

  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

Have we kindled your pioneering spirit?

Then apply now for our location Mainz and simply send us your application documents using our online form.

If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).

Job-ID 6773 (please indicate for inquiries)

We look forward to your application!

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

https://biontech.de