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
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