Validation Specialist
vor 4 Wochen
Our client, a leading biopharmaceutical company, is seeking a highly skilled Validation Specialist to join their team at their new commercial manufacturing site. As a key member of the Center of Excellence for projects and New Product Introductions (NPIs), you will be responsible for ensuring that products and processes meet regulatory requirements and quality standards.
You will support all operational aspects of the MS&T department, including process monitoring, change control, and deviation closure. This role requires strong collaboration with cross-functional teams, including Manufacturing, Quality, Logistics, Facilities, Drug Product Development, and Vendors.
Key responsibilities include:
- Developing and implementing site process validation and revalidation strategies to meet cGMP and quality requirements.
- Collaborating with cross-functional teams to define interfaces for equipment qualification, system qualification, and analytical method validation.
- Establishing and maintaining the Validation Master Plan for process validation.
- Participating in transfers and launches, and aligning with technical development for new products.
- Authoring or reviewing routine validation protocols and reports, associated change controls, and supporting execution at the shop floor.
- Leading and driving investigations for validation-related matters and implementing corrective and preventive actions.
- Contributing to all relevant audit inspections and ensuring inspection readiness for the site.
- Initiating, driving, and implementing continuous improvement initiatives to optimize processes, enhance product performance, and drive operational excellence.
You will be able to work independently and influence and work across organizational boundaries. Strong interpersonal and communication skills, a team player attitude, and a willingness to work in an environment where individual initiative, accountability to the team, and professional maturity are required. Excellent command of English and preferably French language.
gloor&lang AG is the right choice in consultation for life science talents.
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Validation Specialist
vor 2 Wochen
Yverdon-les-Bains, Waadt, Schweiz gloor&lang AG Vollzeit12 months contractor – French speaking necessaryOur client, a leading biopharmaceutical company, is seeking a highly skilled Validation Specialist to join their team at their new commercial manufacturing site. As a subject matter expert in validation processes, you will ensure that products and processes meet regulatory requirements and quality...
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Validation Specialist
vor 1 Monat
Yverdon-les-Bains, Waadt, Schweiz gloor&lang AG Vollzeit{"h2": "Validation Specialist - Pharmaceutical Industry", "p": ["Our client, a leading biopharmaceutical company, is seeking a skilled Validation Specialist to join their team. As a key member of the Center of Excellence for projects and New Product Introductions (NPIs), you will be responsible for ensuring products and processes meet regulatory requirements...
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Validation Specialist
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Yverdon-les-Bains, Waadt, Schweiz gloor&lang AG VollzeitContractor Opportunity - French Language RequiredOur client, a leading biopharmaceutical company, is seeking a skilled Validation Specialist to join their team at their commercial manufacturing site. As a key member of the Center of Excellence for projects and New Product Introductions, you will play a critical role in ensuring products and processes meet...
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Analytical Transfer
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Analytical Transfer and Validation Specialist
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Analytical Transfer and Validation Specialist
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Yverdon-les-Bains, Schweiz Incyte VollzeitAperçu Summary The Specialist / Senior Specialist - Analytical Transfer & Validation supports the transfer and the validation of analytical method and all analytical activities related to the product life cycle, from Raw Materials to DS & DP testing; acts as Subject Matter Expert (SME) for complex problem solving, method improvement, audit and...
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