EINFÜHRUNG:
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).
AUFGABENBESCHREIBUNG:
* 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.
ERFORDERLICHES PROFIL:
* 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 team work.
* 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: