Hybrid GMP Compliance Specialist

Posted 2 months ago

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About the role

  • GMP Compliance Specialist ensuring products meet GMP compliance requirements in production. Involves batch record reviews, monitoring, and training in a pharmaceutical company.

Responsibilities

  • responsible for ensuring that our products fully comply with GMP requirements at all times and are safe for patient use
  • perform batch record reviews of manufacturing documentation
  • generate, maintain and analyze various production-specific metrics for static monitoring
  • initiate change-control procedures, investigate any deviations in production and implement corrective actions
  • provide GMP knowledge through trainings, prepared documents or SOPs
  • participate in customer audits or regulatory inspections and handle complaints
  • prepare project or test plans and reports as needed

Requirements

  • Scientific training, e.g., as a chemical laboratory technician, pharmaceutical-technical assistant (PTA), biological-technical assistant (BTA) or degree in a scientific discipline such as Pharmacy, Pharmaceutical Technology, Biology, Chemistry
  • Experience in the pharmaceutical industry with a GMP compliance background from a production environment, and practical experience in handling CAPA measures, change-control procedures and deviations is mandatory
  • Technical understanding of production equipment
  • Analytical thinking
  • SAP knowledge is an advantage as well as solid Microsoft Office skills
  • Conscientiousness, accuracy and a structured, independent working style
  • Very good German skills (at least C1 level) and good English language skills, both written and spoken
  • Interest and enjoyment in working with a team to develop and implement solutions

Benefits

  • A competitive salary
  • Commuting allowance
  • Contribution to capital-forming benefits (VWL) or company pension plan
  • Company canteen with monthly or daily subsidy for employees
  • EGYM Wellpass
  • Free access to our partner fitness studio (within walking distance)
  • An open and positive working atmosphere
  • Internal and external training opportunities
  • Business bike leasing
  • Free access to the language learning platform Babbel

Job title

GMP Compliance Specialist

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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