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CHChiesi Farmaceutici S.p.A.

Pharmaceutical Affairs Manager(m/w/x)

Wien
from 64,400 / year
Full-timeWith Home OfficeExperienced

Managing change control and SOP harmonization for a global biopharmaceutical group. Several years of GxP experience with change control and TQAs required. Flexible working arrangements, work-life balance initiatives.

Requirements

  • University degree in pharmacy, chemistry, life sciences, pharmaceutical sciences, or comparable scientific discipline
  • Several years of hands-on experience in Pharmaceutical Affairs, Quality Assurance, or comparable regulated environment
  • Proven practical experience with change control, SOP management, deviations, complaints, audits, and TQAs
  • Solid understanding of GxP requirements and quality systems
  • Experience with local and global quality processes and integrating global standards
  • Qualification as a Qualified Person (QP) is advantageous
  • Collaborative, team-oriented mindset and effective cross-functional work
  • Strong communication and interpersonal skills, confident stakeholder interaction
  • Structured, reliable, solution-oriented working style with high ownership
  • Fluent English, written and spoken

Tasks

  • Manage Change Control process
  • Evaluate, coordinate, and document changes
  • Update and maintain SOPs
  • Harmonise SOPs with global procedures
  • Manage Technical Quality Agreements
  • Review and revise TQAs regularly
  • Handle deviations and complaints
  • Support audit planning, execution, and reporting
  • Follow up on corrective and preventive actions
  • Support supplier qualification
  • Review supplier documentation
  • Coordinate with internal and external stakeholders
  • Organise cross-functional meetings
  • Participate in cross-functional meetings

Work Experience

  • approx. 1 - 4 years

Education

  • Bachelor's degree

Languages

  • EnglishFluent

Benefits

Competitive Pay

  • Competitive salary package

Corporate Discounts

  • Top-class benefits

Family Support

  • Work-life balance initiatives

Learning & Development

  • Development opportunities

Flexible Working

  • Flexible working arrangements
  • Remote work options

Other Benefits

  • Tax assistance services for foreign colleagues
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Chiesi Farmaceutici S.p.A. 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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