Quality Assurance Manager

vor 3 Wochen

Biberach an der Riß, Baden-Württemberg, Deutschland GULP – experts united Vollzeit

Are you a pharmaceutical professional seeking a role that combines essential elements such as competitive compensation, expert guidance, and the stability of a globally recognized organization? We have an exciting opportunity for you: we are currently in search of a Validation Manager for a prominent company in the pharmaceutical sector.

What We Offer

  • Competitive salary with long-term job stability through affiliation with a reputable group
  • Comprehensive benefits package, including holiday and vacation bonuses
  • Generous vacation entitlement of up to 30 days annually
  • Company pension scheme contributions post-probation
  • Discounts available for sports, leisure, and wellness activities

Your Responsibilities

  • Take independent charge of product support related to process and cleaning validation, representing the team in interdisciplinary projects, compliance, and client meetings
  • Coordinate validation efforts
  • Plan and execute process and cleaning validations, including the creation, maintenance, or revision of validation documentation (validation master plans, validation reports, sampling plans, risk assessments) in collaboration with relevant departments
  • Conduct independent research and GMP-compliant evaluation of analytical and operational data
  • Collaborate on control strategies, risk assessments, and other documentation with development, production, and analytical teams
  • Assess changes in manufacturing and cleaning processes for validation relevance
  • Evaluate deviations concerning process and cleaning validation
  • Represent validation topics during audits and inspections
  • Assume the role of change manager regarding change management when necessary

Your Profile

  • Master's degree in a natural or technical science with several years of professional experience, or a Bachelor's degree with extensive experience in a GMP environment (pharmaceuticals, biotechnology) or in process and cleaning validation
  • Significant experience in the biopharmaceutical, pharmaceutical, or process engineering fields
  • Thorough understanding of GMP regulations and compliance requirements
  • Proficient in standard MS Office applications
  • Familiarity with SAP and/or TrackWise is a plus
  • Fluent in German with excellent written and spoken English skills
  • High level of initiative, adaptability, and responsibility
  • Ability to work independently and in a structured manner with a strong commitment
  • Strong quality awareness and eagerness to understand process technology

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