Production Qualification Engineer

St.-Prex, Switzerland

Posted: 27-Jun-2018

Ref#: FER-0066 / BR423


Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring or its products please visit www.ferring.com.
In our Headquarter in St-Prex/Lausanne (Switzerland), we are looking for an:

Production Qualification Engineer

Your mission
Owner to manage qualification process of Production system (PQ) and support production projects (FAT -> PQ)

Main responsibilities
  • Although based in Switzerland, the job holder will have to conduct a global role and identify the best sourcing channels for all Ferring entities.
  • Apply and implement related Corporate and ICH guidelines
  • Ensure qualification status for all GxPs systems (Production equipment)
  • Propose and establish qualification strategy based on risk assessment. Write, related qualification protocols and reports, coordinate and execute qualification
  • Activities for Production projects
  • Participate in assessment and execution of Change Control, Deviation and CAPA
  • Timely follow-up of deviations, CAPAs and CCs in collaboration with the production and other departments
  • Active participation during Inspection and Customers Audits (incl. preparation)
  • Participate and propose improvement to SOP qualification review with QA qualification responsible
Required Experience & Competences
  • University degree in relevant scientific/technical discipline
  • Minimum five years’ experience in qualification in the pharmaceutical industry
  • Strong understanding of cGMPs
  • Good knowledge in Regulatory requirements
  • Good knowledge of manufacturing and packaging operations
  • Autonomy in the daily business
  • Good experience in Pharmaceutical field
  • Good verbal communication and communication skill (incl. English)
  • Able to make quality decision on time

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