Quality Assurance Associate
On a 12-month contract, with possibilities of extension.
Main Responsibilities
* Provide expert support and advisory services in aseptic manufacturing and microbiological laboratories.
* Verify and ensure adherence to GMP standards throughout production processes.
* Control, review, and document aseptic production workflows and processes.
* Support production teams with compliance and risk assessment during manufacturing, including on-call duties.
* Manage deviations in aseptic filling: conduct initial assessments, assist in defining investigation strategies and evaluate technical assessments, collaborate with operations to investigate deviations and define corrective and preventive actions (CAPAs), review investigation reports in German and English, assessing compliance and risk.
* Assist in preparing documentation for internal and external inspections related to deviations.
* Support the review and update of procedural and regulatory documents.
Qualifications and Experience
* Relevant working/residency permit or Swiss/EU-Citizenship required.
* Degree in a natural science field (Bachelor, Master, or PhD) or equivalent qualification.
* Experience or knowledge of GMP and pharmaceutical industry practices is advantageous.
* Strong analytical skills with the ability to quickly grasp logical connections and present them clearly and structured.
* Good understanding of report and document structure with a critical eye for detail.
* Native-level German and very good English skills, both written and spoken.
#J-18808-Ljbffr