Senior Qualification Specialist (CQV)Start Date: ASAPLocation: Visp, SwitzerlandAbout the RoleOur client, a leading pharmaceutical and biotechnology company, is seeking a Senior Qualification Specialist to join its team in Visp, Switzerland.In this role, you will be responsible for supporting commissioning, qualification, and validation activities for GMP-regulated equipment and facilities. You will play a key role in ensuring compliance, operational excellence, and the successful delivery of critical projects within a fast-paced manufacturing environment.Key ResponsibilitiesDevelop, review, and maintain Commissioning, Qualification, and Validation (CQV) documentation.Execute and approve IQ, OQ, and PQ protocols for critical systems and equipment.Lead and support deviation investigations, CAPAs, and Change Control activities.Manage equipment and system lifecycle activities following implementation.Coordinate qualification activities with internal stakeholders, suppliers, and external service providers.Support audits, inspections, and regulatory submissions by presenting qualification documentation.Ensure compliance with GMP requirements, internal procedures, and industry best practices.Drive continuous improvement initiatives to enhance quality, compliance, and operational efficiency.RequirementsBachelor’s degree or higher in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related technical field.Minimum 5 years of experience in a GMP-regulated environment with a strong background in Commissioning, Qualification Validation (CQV).Experience qualifying process equipment, clean utilities, refrigerators, freezers, and critical GMP systems.Solid knowledge of GMP regulations, Change Control, Deviations, Investigations, and CAPA processes.Proficiency with MS Office; experience with Kneat, TrackWise, SAP, COMOS, or DMS is considered an advantage.Fluent in English; German is a strong asset.Strong organizational, communication, and problem-solving skills.Ability to work independently while collaborating effectively within multidisciplinary teams. #J-18808-Ljbffr
Qualification & Validation in Sierre Arbeitgeber: Gi Group
Unser Kunde in der Region Olten ist ein hervorragender Arbeitgeber, der seinen Mitarbeitenden nicht nur kostenlose Parkplätze und eine gründliche Einarbeitung bietet, sondern auch ein angenehmes Arbeitsumfeld fördert. Die flexible Schichtarbeit ermöglicht es den Mitarbeitenden, ihre Work-Life-Balance zu gestalten, während die Möglichkeit zur Übernahme von Verantwortung und die Unterstützung bei der persönlichen Weiterentwicklung wertvolle Wachstumschancen bieten. Hier wird Teamarbeit großgeschrieben, und die positive Unternehmenskultur sorgt dafür, dass sich jeder Mitarbeiter geschätzt und motiviert fühlt.
