pSenior Qualification Specialist (CQV) /ppbStart Date: /b ASAP /ppbLocation: /b Visp, Switzerland /ph3About the Role /h3pOur client, a leading pharmaceutical and biotechnology company, is seeking a bSenior Qualification Specialist /b to join its team in bVisp, Switzerland /b. /ppIn 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. /ph3Key Responsibilities /h3ulliDevelop, review, and maintain Commissioning, Qualification, and Validation (CQV) documentation. /liliExecute and approve IQ, OQ, and PQ protocols for critical systems and equipment. /liliLead and support deviation investigations, CAPAs, and Change Control activities. /liliManage equipment and system lifecycle activities following implementation. /liliCoordinate qualification activities with internal stakeholders, suppliers, and external service providers. /liliSupport audits, inspections, and regulatory submissions by presenting qualification documentation. /liliEnsure compliance with GMP requirements, internal procedures, and industry best practices. /liliDrive continuous improvement initiatives to enhance quality, compliance, and operational efficiency. /li /ulh3Requirements /h3ulliBachelor’s degree or higher in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related technical field. /liliMinimum 5 years of experience in a GMP-regulated environment with a strong background in Commissioning, Qualification Validation (CQV). /liliExperience qualifying process equipment, clean utilities, refrigerators, freezers, and critical GMP systems. /liliSolid knowledge of GMP regulations, Change Control, Deviations, Investigations, and CAPA processes. /liliProficiency with MS Office; experience with Kneat, TrackWise, SAP, COMOS, or DMS is considered an advantage. /liliFluent in English; German is a strong asset. /liliStrong organizational, communication, and problem-solving skills. /liliAbility to work independently while collaborating effectively within multidisciplinary teams. /li /ul #J-18808-Ljbffr
Qualification & Validation in Raron 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.
