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BABayer

Quality Assurance Specialist(m/w/x)

Berlin
from 77,300 - 93,800 / year
Full-timeWith Home OfficeExperienced

GMP-compliant manufacturing oversight for parenteral pharmaceutical products at a global health and agriculture company. Licensed pharmacist with initial experience in drug risk assessment and regulations required. Company daycare centers, childcare support.

Requirements

  • Degree in pharmacy and licensed pharmacist
  • Initial professional experience in pharmaceutical manufacturing, testing, or evaluation
  • Strong understanding of drug risk assessment, national/international regulations, and GMP environment
  • Proficiency in IT systems such as MS Office
  • Ability to analyze technical processes and derive targeted measures
  • Strong organizational and excellent communication skills
  • Leadership qualities: independent work, assertiveness, communication, flexibility, resilience
  • Strong focus on quality and cost awareness
  • Fluency in German and good written/spoken English

Tasks

  • Ensure GMP-compliant manufacturing of pharmaceutical products
  • Collaborate with Production, QA, and QC teams
  • Oversee pharmaceutical production facilities for parenteral products
  • Adhere to GMP guidelines and pharmaceutical regulations
  • Create and update pharmaceutical-related documents
  • Prepare manufacturing instructions per Section 13 AMWHV
  • Develop and maintain SOPs
  • Conduct investigations for process deviations
  • Prepare investigation reports with QA/QC
  • Ensure validations of manufacturing processes
  • Train production staff as per §12 AMWHV
  • Initiate Change Control measures
  • Review manufacturing records
  • Handle customer complaints
  • Manage inspection and audit preparations
  • Follow up on inspections and audits
  • Ensure GMP compliance in projects and processes
  • Optimize GMP compliance for cost-effectiveness
  • Supervise practical training of pharmacy interns per §4 AappO

Work Experience

  • approx. 1 - 4 years

Education

  • Bachelor's degree

Languages

  • GermanNative
  • EnglishBusiness Fluent

Tools & Technologies

  • MS Office

Benefits

Bonuses & Incentives

  • Variable compensation component

Flexible Working

  • Flexible work models
  • Part-time arrangements

Childcare

  • Company daycare centers
  • Childcare support
  • Summer camps for children

Family Support

  • Time off for family care

Learning & Development

  • Learning and development opportunities
  • Training programs

Mentorship & Coaching

  • Development dialogues
  • Coaching and mentoring programs

Healthcare & Fitness

  • Health checks

Informal Culture

  • Inclusive work environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bayer and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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