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Operations compliance / quality specialist (m/f) 100%

Kaiseraugst
univativ Schweiz AG
EUR 90’000 pro Jahr
Inserat online seit: 11 März
Beschreibung

Your expertise is in demand: univativ connects you with companies that rely on professional competence and solid know-how. Whether you want to enrich your career with exciting projects, contribute your knowledge in responsible positions, or develop yourself in a new environment.

For an internationally operating company in a regulated environment, we are looking for two experienced professionals in the area of Operations Compliance / Quality. In this role, you will support the laboratory organization in quality-related processes and actively contribute to ensuring GMP-compliant operations.


Das erwartet Dich bei uns

* Manage QC-related deviations, root cause investigations, CAPAs, and change controls
* Maintain and revise QC-specific controlled documents (e.g., test methods, SOPs, forms, logbooks)
* Implement CAPA within agreed timelines and support training on procedures.
* Support data integrity activities and ensure correct, complete, and consistent documentation
* Conduct or support QC-related risk assessments and mitigation activities.
* Monitor QC quality metrics (e.g., deviation trends, cycle times, data integrity observations)
* Collaborate with laboratory team leaders and QA to resolve quality issues promptly
* Ensure proper implementation of changes impacting QC workflows, systems, or methods


Das bieten wir Dir

* Responsible and varied role
* Short decision-making paths and direct communication
* Collaborative environment with cross-functional teamwork
* Opportunity to actively shape and further develop processes


Deine Qualifikationen

* Several years of experience in a pharmaceutical QC environment or in a regulated laboratory
* Solid GMP knowledge
* Experience in conducting investigations and root cause analyses
* Very structured, reliable, and detail-oriented working style
* Experience with electronic quality systems and LIMS is an advantage
* Strong documentation and communication skills
* Fluent English (written and spoken); German or French is an advantage
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