As a preferred supplier for Roche in Basel, we are looking for an individual.
Quality Assurance Manager (m/f/d)
This is a full/part-time position (80-100%) with a 3-year project duration. The ideal start date is asap or 01.03.2025. Home Office is possible up to 40% (Monday and Wednesday onsite days).
Responsibilities
* You have end-to-end quality oversight on the qualified state of all assets in your assigned area.
* You provide fit for purpose quality support for all the activities related to qualification & CSV, calibration, maintenance & reliability engineering.
* You review and approve GMP records that cover technical change management, deviation management & CAPAs, risk assessments and SOPs.
* You coordinate and facilitate complex investigations, root cause analyses, technical risk assessments, and continuous improvement projects.
* With your operations partner you present topics during health authority inspections and internal audits.
Minimum Requirements
* University degree in science or engineering.
* Min. 3 years demonstrated experience in Quality Assurance at a pharmaceutical manufacturing site.
* Practical experience in commissioning & qualification projects in highly automated GMP production facilities.
* Well established confidence in setting precise guidance for QA compliance in technical changes, deviations and CAPAs.
* Your collaboration with partners is characterized by outstanding communication and teamwork.
* You manage to drive quality awareness with operations partners at all levels by integrating regulatory requirements, analytical problem solving and scientific rationale.
* Excellent German and English language skills, both written and spoken.
Application Process
Interested? You can find more information here: Infopackage. Please apply via the "Bewerben" button below and answer all questions, otherwise we will be unable to process your application. Please upload your CV in English or German only, along with your degree certificate and latest reference letter.
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