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Scale-up Manager for Optimization & Statistics

Place of work: Vršac

Requirements:

  • University Degree in the field of Pharmacy, Chemistry, Biology or related field
  • Minimum 2 years of experience in Pharmaceutical Development, Manufacturing or Quality Assurance
  • Fluent English both verbally and in writing
  • IT Skills in MS Office and Statistics Software (MiniTab, Statistica)
  • Good knowledge of EU Guidelines and of statistical process analysis

 

Your duties would include:

  • Scale-up projects from lab-scale to commercial scale in the target sites
  • Involvement in Investigations on deviations
  • Lead Optimization projects to enhance product performance and/or to improve process and formulations
  • Run statistical assessments of the products and enable them for Ongoing Process Verification
  • Remove issues and barriers to successfully lead the projects
  • Derive Risk – Assessments that consider e.g. formulation, production process and the environmental conditions
  • Cooperate with manufacturing department and QA to implement the best possible solutions
  • Clarification of feasibility and execution of Scale-ups to the target site
  • Check that GMP documents are correct for Scale-up and Optimization projects
  • Monitor and execute Process Challenge during production
  • Define requirements for stability studies (ICH, ongoing, bulk, transport studies)

 

We offer:

  • Diverse, challenging and responsible tasks
  • Possibility of promotion and achieving a career progression
  • Private Health Insurance

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