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LOLonza

QA Project Manager - Drug Product(m/w/x)

Visp
Full-timeOn-siteExperienced

Establishing Quality Agreements for manufacturing, representing the quality function in project teams and customer technical transfers. Long-term GMP pharmaceutical industry experience required. Customer-facing role with technical transfer focus.

Requirements

  • University degree or equivalent in Chemistry, Biology, Biotechnology, or related field
  • Long-term experience in GMP pharmaceutical industry environment
  • Advantageous: QA department experience
  • Business fluent English
  • Advantageous: German language skills

Tasks

  • Establish Quality Agreements (QAA) with DPS and LONZA DS sites.
  • Represent QA in project teams.
  • Represent QA in customer meetings during technical transfer.
  • Serve as QA contact for specific projects.
  • Manage customer interface for DRs and CRs.
  • Serve as point of contact for customer QA inquiries and complaints.
  • Organize customer audits with compliance and DPS teams.
  • Support and approve project and regulatory risk assessments.
  • Review and release product documentation (e.g., protocols, test plans).
  • Collaborate with QC-PL and MSAT for New Product Introductions (NPIs).
  • Support inspection organization (front and back office).
  • Represent Drug Product QA during regulatory inspections.
  • Support continuous improvement for Visp DPS Quality Management System (QMS).
  • Represent QA in cross-functional teams.
  • Establish and maintain interfaces with manufacturing, QC, and engineering.
  • Facilitate technology transfer for drug products.
  • Assess, review, and approve quality records and release dossiers.
  • Manage deviations, change controls, and CAPAs.
  • Conduct investigations and effectiveness checks.
  • Handle complaints and APR/PQRs.

Work Experience

  • approx. 1 - 4 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent
  • GermanBasic

Benefits

Career Advancement

  • Agile career

Informal Culture

  • Dynamic working culture
  • Inclusive workplace

Purpose-Driven Work

  • Ethical workplace

Competitive Pay

  • High-performance compensation programs

Other Benefits

  • Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza 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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