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Quality Assurance Specialist. Bern / Berne. Suiza
Ofertas en Bern / Berne (Suiza) de Ingenieros industriales y de producción
Clasificación del trabajo: Profesionales científicos e intelectuales › Profesionales de las ciencias y de la ingeniería › Ingenieros (excluyendo electrotecnólogos) › Ingenieros industriales y de producción.
Traducción de la profesión: Akademische Berufe › Naturwissenschaftler, Mathematiker und Ingenieure › Ingenieurwissenschaftler (ohne Elektrotechnik, Elektronik und Telekommunikation) › Wirtschafts- und Produktionsingenieure.
Descripción de la oferta de trabajo:
Join our team at TechFirm Industrial Services as:
QUALITY ASSURANCE SPECIALIST (w/m/d)
in the GMP environment here in Switzerland!
We are looking for the following qualifications and experience:
**Core Responsibilities**
• Verification of the companies compliance with ISO/cGMP quality system requirements as well as knowledge of PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.
• Provide immediate support to operations and quality control staff to address compliance related concerns (QA on-the-floor support).
• Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams. Audit internal quality system elements in manufacturing and operational support areas.
• Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations.
• Perform external audits of suppliers/vendors/off-site facilities.
• Act as a customer interface during on-site audits, conference calls and other standard means of communication.
• Independently identify and manage special projects or QA compliance functions as agreed upon with QA management.
• Prioritize and manage a variety of projects simultaneously.
• May need to lead and direct the work of others.
• Review and approve validation documents.
• Review and Master Batch Records (MBR) and supporting documents.
• Perform review/release of batch records, as needed.
**Qualifications and Experience**
• Master or Engineering degree in Life science, Biotechnology or Pharmaceutical area
• Min. 3-5 years work experience
• Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience.
• GMP compliance and Part 11 compliance knowledge preferred.
• Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
• Excellent written and oral communication to include accurate and legible documentation skills.
• Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
Interested to have a first chat and get on board at Techfirm? Then don't hesitate to submit your application together with your CV indicating your previous experience related to this position.
País del trabajo: Suiza.
Región: Bern / Berne.
Ver 263 ofertas de trabajo en "Bern / Berne" (Suiza).
Número de puestos: 1.
Empleador: Tech'Firm Industrie AG.
Instrucciones para solicitar:
g.killigtechfirm.ch
Forma de contacto:
- Teléfono: +41 76 489 41 65
- Sitio web: g.killigtechfirm.ch
Oferta de trabajo obtenida del portal Eures, con fecha 13 de Julio de 2024, y con identificador de la vacante:04ca9e77-27eb-11ef-80d3-0e8175683808.
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