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BABayer

Quality Assurance Manager - Premises & Equipment(m/w/x)

Leverkusen
from 88,900 - 108,000 / year
Full-timeWith Home OfficeExperienced

Ensuring production infrastructure quality and compliance for pharmaceutical manufacturing. EU GMP, CFRs, and validation expertise required. Hybrid work, variable compensation.

Requirements

  • Completed scientific or engineering degree, or comparable extensive practical experience
  • Proven leadership capabilities and ability to motivate
  • In-depth know-how in EU GMP Volume IV, AMG, CFRs
  • In-depth know-how in qualification and validation processes
  • In-depth know-how in pharmaceutical documentation & data integrity
  • In-depth know-how in technical fundamentals in GMP environment and engineering processes
  • Enjoyment of working in a highly interconnected environment
  • Strong communication and decision-making skills
  • High reliability and quality awareness
  • Ability to act confidently under pressure
  • Fluent German at negotiation level
  • Fluent English at negotiation level

Tasks

  • Guarantee production infrastructure quality and compliance
  • Oversee qualification, maintenance, and calibration of equipment
  • Monitor global production capability according to regulatory requirements
  • Review and approve qualification documents and risk analyses
  • Evaluate deviations and CAPAs, create sustainable solutions
  • Collaborate with production, QC, engineering, logistics, and cross-site teams
  • Continuously improve processes and present during inspections
  • Participate in Quality Management System development
  • Drive training and improvement initiatives

Work Experience

  • approx. 1 - 4 years

Education

  • Bachelor's degree

Languages

  • GermanBusiness Fluent
  • EnglishBusiness Fluent

Tools & Technologies

  • EU GMP Volume IV
  • AMG
  • CFRs

Benefits

Bonuses & Incentives

  • Variable compensation component

Flexible Working

  • Hybrid work models
  • Part-time arrangements
  • Flexible work 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 programs
  • Mentoring programs

Healthcare & Fitness

  • Health awareness promotion
  • Free health checks

Mental Health Support

  • Self-care opportunities

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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