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F.F. Hoffmann-La Roche AG

Complaint Lead Investigator(m/w/x)

Kaiseraugst
Full-timeOn-siteSenior

Processing external complaints for drug products in a pharmaceutical setting. Understanding of quality and compliance fundamentals essential. Focus on patient safety and product quality for life-saving drug products.

Requirements

  • Responsibility, determination, and result-oriented mindset
  • Ability to build trusting relationships
  • Understanding of quality and compliance fundamentals
  • Very good organizational skills
  • Strategic thinking and planning skills
  • Ability to maintain inspection readiness
  • Degree in Pharmacy, Microbiology, Chemistry, Biochemistry, Device Engineering or equivalent
  • Ideally 2 years pharmaceutical industry experience
  • Experience in a GMP-regulated environment
  • Expert knowledge of pharmaceutical quality systems
  • Expert knowledge of pharmaceutical cGMP regulations
  • Cross-functional collaboration and investigation management skills
  • Business-fluent English and German skills

Tasks

  • Coordinate and process external complaints independently
  • Follow current GMP rules and regulatory requirements
  • Document investigations accurately and completely
  • Create and evaluate trend analyses
  • Identify potential quality problems through data
  • Escalate critical complaints to leadership and stakeholders
  • Participate actively in root cause analyses
  • Present critical complaints at QRB and GEG
  • Collaborate on-site to develop cross-functional solutions
  • Define action plans and corrective measures
  • Prioritize tasks to meet deadlines and goals
  • Manage competing priorities through effective escalation
  • Present complaint investigations during audits and inspections

Work Experience

  • 2 years

Education

  • Vocational certificationOR
  • Bachelor's degree

Languages

  • EnglishBusiness Fluent
  • GermanBusiness Fluent

Tools & Technologies

  • GMP
  • cGMP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of F. Hoffmann-La Roche AG 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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