QC Lab Specialist

☞ Ferring Pharmaceuticals

Visualizza: 163

Giorno di aggiornamento: 29-03-2024

Località: Saint-Prex Vaud VD

Categoria: Garanzia di qualità / Controllo di qualità

Industria: Medical Equipment Manufacturing Research Services Pharmaceutical Manufacturing

Tipo di lavoro: Full-time

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Contenuto del lavoro


Job Description:

Mission:
 As QC Specialist, you will have an extended area of responsibility within apparatus, technology and analytical methods. You will assist the Quality Assurance, Production and R&D Departments in investigations regarding analytical results and interpretations. You will provide direct support to the QC Raw Material team in due time with the right level of quality and compliance. You will also ensure the daily management of deviation and investigation for the Raw Material team.

Your main responsibilities will be:

  • Supervises the daily work for lab event, deviation and phase I investigation. This include support for the investigation, record in the defined system, evaluation and closure with QA
  • Reviews and approves analytical test results for completeness and accuracy using LIMS
  • Review and approval of SOPs, work instructions and risk assessments
  • Monitors results for trends; and implement Change Control, CAPAs as needed using QA Track
  • Develops and maintains applicable laboratory procedures, test methods, specifications, documentation and records
  • Support for the training of Team members
  • Applies Lean techniques with Team members. Ensure and control the respect to the defined standard
  • Participates in Lab Audits and Inspections
  • Participation in QC projects, including Lean and Six Sigma, New technology.
  • Ensures the laboratory is kept in a safe working environment and in compliance with OSHA and other requirements and other laboratory safety standards


Required profile:

  • Federal Certificate of Capacity (CFC) or Bachelor/Master Degree in Life Sciences
  • 5 to 10 years experience in the QC Pharmaceutical industry as chemical technician
  • Excellent knowledge of pharmacopeia (PhEur, USP, JP, etc.)
  • Demonstrated knowledge of GMPs, FDA and other regulatory requirements is required
  • Knowledge in Medical Device and Microbiology is a plus
  • Advanced knowledge of analytical methods and testing required
  • Fluent in French
  • English is a must



Location:Switzerland SMP - St Prex

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Scadenza: 13-05-2024

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