Specialist OQA GMP Compliance & Master Records (all genders)

Mainz, Germany   |   full time   |   hybrid   |   Job ID: 8062 

 

 

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 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 master records and templates used for the review and release of GMP products

• Ensure GMP compliance of the batch record review process as well as related processes to this topic

• 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

 

 

Your Benefits:

 

It's our priority to support you:

• Your flexibility: flexible hours | vacation account  
• Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential.
• Your health and lifestyle: Company bike
• Your mobility: Job ticket | Deutschlandticket 
• Your life phases: Employer-funded pension | Childcare 

 

 

Apply now - We look forward to your application!

 

Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6781 9855 211 (Monday-Friday from 12 PM to 4 PM CET).

 

Job ID 8062 (please always specify if you have any questions)   

 

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your Recruiter.