QA Manager, GMP

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.

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