Specialist OQA GMP Compliance & Master Records
Become a member of the BioNTech Family!
As a part of our team of more than 5.000 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 OQA GMP Compliance & Master Records
Specialist* QA GMP Compliance & Master Records
As a Specialist* QA GMP Compliance & Master Records, you will ensure that master records, validation protocols, etc. are well documented, reviewed and approved by QA. In addition, this position assures the training management within the OQA Mainz and supports general GMP compliance at the site.
Your main responsibilities are:
- Contribute that controlled documents are well documented, reviewed and approved by QA, with includes batch records of diverse projects and manufacturing steps
- Support the design and review of documents and templates for GMP related processes and ensure GMP compliance
- GMP compliance support and main contact for OQA training management.
- Initiating, implementing and monitoring change controls, deviations and CAPAs
- Follow-up with Key Quality Metrices (KPIs) as required
What you have to offer:
- Apprenticeship with a scientific background or university degree (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:
- Flexible Working Time
- Work from EU Countries (up to 20 days per year)
- Company Pension Scheme
- Childcare
- Jobticket
- Company Bike
- Leave Account
- Fitness Courses
... and much more.
Have we kindled your pioneering spirit?
Then apply now for our location Mainz Goldgrube 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 6920 (please indicate for inquiries)
We look forward to your application!
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
BioNTech - As unique as you
www.biontech.com