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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 projects. 3-5 years in GMP analytical labs required. Childcare facilities, modern pension scheme.

Requirements

  • University degree or FH with natural science/technical background or equivalent education
  • 3-5 years in pharmaceutical industry and/or analytical laboratory in GMP environment
  • MS Office and standard IT applications
  • Fluent English
  • Fluent German
  • Collaboration skills
  • Communication skills
  • Data integrity knowledge
  • Dealing with ambiguity
  • Decision making skills
  • Digital savviness
  • Leadership skills
  • Operational excellence
  • Problem solving skills
  • Regulatory requirements knowledge

Tasks

  • Coordinate and manage analytical activities
  • Support customer-related and Novartis projects
  • Provide scientific analytical expertise
  • 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
  • Act as analytical subject matter expert during audits
  • Interface with Manufacturing Science & Technology team
  • Collaborate with analytical development, production, quality assurance, and regulatory departments
  • Implement GMP requirements
  • Compile and review analytical protocols
  • Review annual performance quality reports
  • Review ongoing process verification reports
  • Review registration documents
  • Budget and control external analytical activities
  • Manage reference substances and control samples

Work Experience

  • 3 - 5 years

Education

  • Vocational certificationOR
  • Bachelor's degree

Languages

  • English – Business Fluent
  • German – Business 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

Diverse Work

  • Advice on suitable positions

Mentorship & Coaching

  • Guidance at all stages of the application process
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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