QA Operations Manager - Qualified Person

Posted 20 August 2021
LocationLes Genevez (JU), Franches-Montagnes District, Canton of Jura, Switzerland
Job type Permanent
DisciplineLife Sciences, Logistics/Transportation/Supply Chain

Job description

For our client, localized in the French part of Switzerland for its pharmaceutical department, we are looking for a :

QA Operations Manager

Your responsibilities

  • Act as the Qualified Person manufacturing and distribution activities
  • Ensure authorized activities management and records accuracy and quality
  • Ensure QMS implementation and maintenance
  • Create, modify and maintain GMP, GDP, Quality system
  • Handle of GDP Documentation, quality agreements
  • Conduct internal audits: prepare annual audit plan and self-auditing
  • Conduct external audits: suppliers, CMO and distributors
  • Be the contact point for Swiss medic
  • Be in charge of Customer qualifications, Change control, CAPA (Corrective and Preventive Actions)
  • Handle complaints, deviations and returns: decide on the final disposition of returned, rejected, recalled or falsified products and approve any returns to stock
  • Ensure risk management activities, recall management
  • Ensure training plan

Your profile

  • Master in Chemistry, Biotechnology, Life sciences or Pharmacist
  • Minimum a 5-year experience in pharmaceutical industry, preferred in biotechnology
  • Strong knowledge and experience with GMP, GDP (Good Distribution practice), EMA Guidelines. Experience with Swissmedic registration process and regulations (highly desired)
  • Mandatory experience in quality, preferred as a QP
  • Solid experience in effective usage of data analysis tools and statistical analysis
  • Fluent in French & English

Your application
Please apply on-line. For more information, contact Ms Sophie Darthenay