QC Regulatory Specialist

☞ Ferring Pharmaceuticals, Inc.

Aussicht: 114

Update Tag: 24-04-2024

Ort: Saint-Prex Vaud VD

Kategorie: Pharma / Chemie / Biotechnologie

Industrie:

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Jobinhalt

Job Description:
Ferring+You
You will be part of the QC Projects & Continuous Improvement team, a dynamic, positive spirit and close-knit group working on analytical validation and many continuous improvement and compliance projects in the QC Laboratory.
Your day at Ferring
  • Management of QC projects and responsible for the analytical part of Site projects (scheduling, organization, coordination, reporting)
  • Ensure the follow-up of regulatory topics. Work in collaboration with the Regulatory QA department on the drafting of regulatory documents and responses to deficiency letters
  • Lead cross-functional investigations to determine root cause of OOS and other non-compliant results. Implement appropriate corrective and preventative action plans
  • Liaise with other Departments including Quality Assurance, Manufacturing, Pilot Plant and Facilities to address compliance issues, to implement corrective actions and to improve programs
  • Develop and maintain applicable laboratory procedures, test methods, specifications, documentation and records to ensure compliance in accordance with regulations
  • Serve as SME during audits and inspections
Behind our innovation…There’s you
  • Master’s degree in Chemistry, Pharmacy or CFC in Chemistry with at least 5 years experience in the Pharmaceutical industry
  • 3 to 5 years experience in Regulatory Affairs is a plus
  • Technical skills in chemical analytical procedures
  • Proven working knowledge of Pharmacopeias (Ph.Eur., USP, JP), GMP and ICH guidelines
  • Language: French and English (fluent, speaking & writing)
  • IT: Excellent knowledge of Office 365 (Word, Excel) and LIMS
  • Soft skills : ability to take initiatives and work independently while developing and maintaining effective communication with stakeholders without formal authority; ability to work in “project mode” and deal with changes; strategic thinking
Location:
Switzerland SMP - St Prex
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Frist: 08-06-2024

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