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QA Manager, GMP
☞ PharmiWeb.jobs: Global Life Science Jobs
View: 141
Update day: 25-04-2024
Category: Quality Assurance / Quality Control
Industry: Staffing Recruiting
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)
- 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
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Deadline: 09-06-2024
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