Analytik NEWS
Online Laboratory Magazine
06/28/2022

Specialist QA GMP Compliance & Master Records (m/f/d)

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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

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


» Job description


Employer:
BioNTech AG
Location:
55131 Mainz
Temporary:
No
Part-time:
No