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NONovartis Pharmaceutical Manufacturing GmbH

AS&T Expert(m/w/x)

Schaftenau
from 60,600 / year
Full-time, Part-timeOn-siteExperienced
Apply now

Managing analytical method transfers and stability studies for pharmaceutical products. Pharmaceutical industry experience in a GMP environment required. Childcare facilities, modern pension scheme.

Requirements

  • University degree or FH with natural science/technical background or equivalent education
  • Pharmaceutical industry and/or analytical laboratory experience in GMP environment
  • English fluency
  • German fluency
  • Collaboration skills
  • Communication skills
  • Data integrity knowledge
  • Dealing with ambiguity skills
  • Decision making skills
  • Digital savviness
  • Leadership skills
  • Operational excellence knowledge
  • Problem solving skills
  • Regulatory requirements knowledge

Tasks

  • Coordinate and manage analytical activities
  • Manage analytical method transfers and stability studies
  • Present and discuss analytical data in project teams
  • Manage analytical method life cycle
  • Control method performance and validation
  • Ensure pharmacopoeia and health authority compliance
  • Define method improvements
  • Handle deviations, investigations, and OOS/OOE/OOT cases
  • Manage changes and complaints
  • Serve as contact for health authority questions
  • Provide analytical expertise during audits and inspections
  • Interface with Manufacturing Science & Technology team
  • Collaborate with analytical development, production, quality assurance, and regulatory departments
  • Implement GMP requirements
  • Compile and review analytical documents
  • Prepare annual performance quality reports
  • Conduct ongoing process verification
  • Prepare registration documents
  • Budget and control external analytical costs
  • Manage reference substances and control samples

Work Experience

  • 3 - 5 years

Education

  • Compulsory education

Languages

  • English – Fluent
  • German – Fluent

Tools & Technologies

  • MS Office

Benefits

Competitive Pay

  • Market-competitive base salary

Bonuses & Incentives

  • Attractive incentive program

Retirement Plans

  • Modern company pension scheme

Childcare

  • Childcare facilities

Learning & Development

  • Learning and development opportunities

Career Advancement

  • Worldwide career possibilities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharmaceutical Manufacturing GmbH 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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