Overview
Senior QA Expert for QC on a 6-month contract (60% workload) based onsite in Stein. You will provide quality oversight for QC activities, ensure GMP compliance, and support gLIMS implementation within cross-functional projects aligned to site objectives. You’ll review GMP-relevant documents, manage QA/QC deliverables, and own SOPs related to your expertise. This role focuses on driving compliant QC operations and enabling growth projects in a regulated manufacturing environment.
Verantwortungsbereiche
- Collaborate with cross-functional teams to meet site quality objectives and project timelines
- Provide quality oversight for QC and support growth projects
- Lead QA input for the gLIMS implementation and act as QA point of contact
- Ensure GMP compliance and SOP adherence across QC
- Review and approve GMP documents, focusing on gLIMS implementation
- Supervise GMP compliance activities including changes (CRs), document management, and non-conformities (DRs)
- Write or revise SOPs in area of expertise and own these documents
- Support QC raw data review as required
- Meet internal and external guidelines on quality and safety (GMP, SOPs, regulations)
- Manage and report KPIs and participate in inspections/audits
- Perform other duties as assigned
Zentrale Anforderungen
- 8 years+ experience in projects implementing laboratory execution systems within a quality-focused environment
- 7+ years Quality Assurance experience (QA and/or QC mix acceptable)
- 2+ years of LIMS experience
- Strong knowledge of cGMP regulations (US, European, Japanese Pharmacopoeia)
- Experience with laboratory equipment/software qualification/validation
- Experience interacting with health authorities (FDA, Swissmedic)
- Fluent in English; German nice to have
- Project management certification considered an advantage
- Collaborative and cross-functional communicator
- Structured, organized, and proactive
- Open-minded, agile, motivated and solution-oriented
- LIMS / gLIMS experience
- GMP compliance expertise
- SOP development and document management
Senior QA Expert for QC Specialist in Basel Arbeitgeber: CTC Resourcing Solutions
CTC Resourcing Solutions bietet eine herausragende Arbeitsumgebung für Fachkräfte im Bereich Biotechnologie und Pharma. Mit einem starken Fokus auf Teamarbeit und interdisziplinäre Zusammenarbeit in Visp, Schweiz, fördern wir eine Kultur der kontinuierlichen Verbesserung und beruflichen Weiterentwicklung. Unsere Mitarbeiter profitieren von flexiblen Arbeitszeiten, umfassenden Schulungsprogrammen und der Möglichkeit, an innovativen Projekten in einer dynamischen Branche teilzunehmen.
