QA Manager, Gmp - Geneve, Schweiz - Proclinical
Beschreibung
Proclinical are recruiting a QA Manager, GMP for an innovative pharmaceutical company. This role is on a permanent basis and is located in Geneva.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 followup 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 followup 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 cooperative 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
- Customerfocused value creation
- Collaboration beyond boundaries
- Integrity and trust
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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QualityAssurance
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