Position: Mid-Senior level

Job type: Full-time

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Job content

Proclinical are recruiting a QA Manager, GMP for an innovative pharmaceutical company. This role is on a permanent basis and is located in Geneva.Job Responsibilities
  • Oversight CMO operations including validations physically whenever an independent witness is needed
  • Overall management of change control for the products manufactured at CMO
  • Review of deviations and investigations related products manufactured at CMO
  • Overall responsible for follow-up of CMO CAPA execution on timely manner
  • Preparation of Product Quality Review Reports for the products manufactured at CMO
  • Batch documentation review
  • Lead QA meetings with CMOs and reporting the outcome to other regions
  • Lead the Quality KPI follow-up and trends and reporting
  • Work closely with Japan, Asia, North America, EMEA Quality, EMEA supply chain and EMS and EMEA RA and with external stakeholders to ensure quality compliance of ophthalmic products at CMO
  • Act a deputy RP in Switzerland (if location is GVA)
Skills And Requirements
  • M.Sc or B.Sc in biology, pharmacy, chemistry or relevant area
  • Fluent English
  • Fluent French
  • A minimum of five year experience working in a pharmaceutical industry
  • Experience working in a multinational environment at least 2 years
  • Knowledge of sterile aseptic manufacturing
  • Strong EU GMP and US GMP knowledge
  • Work experience from different functions of pharmaceutical industry (e.g. manufacturing)
  • Collaboration with Contract Manufacturing Organisations
  • Leadership experience
  • Excellent co-operative skills in international business
  • Asian culture knowledge
  • Independent initiative
  • Accuracy
  • Excellent organizational skills
  • Excellent project management skills
  • Ability to solve problems and making decisions
  • Advanced computer skills
  • Advanced MS Office skills (Word, Excel, PowerPoint, Outlook, SharePoint,Visio)
  • Advanced skills in TrackWise (QM) and VeevaVault
  • SAP skills
  • Customer-focused value creation
  • Expertise application
  • Collaboration beyond boundaries
  • Integrity and trust
If you are having difficulty in applying or if you have any questions, please contact Josh Godden on +44 203 854 0101.Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.Proclinical Staffing is an equal opportunity employer.#QualityAssurance
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Deadline: 09-06-2024

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