Job Responsibilities
* You have end-to-end quality oversight on the qualified state of all assets in your assigned area.
* Provide fit for purpose quality support for all the activities related to qualification, CSV, calibration, maintenance, and reliability engineering.
* Review and approve GMP records that cover technical change management, deviation management, CAPAs, risk assessments, and SOPs.
* 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 Qualifications
* University degree in science or engineering.
* Demonstrated experience in Quality Assurance at a pharmaceutical manufacturing site.
* Practical experience in commissioning and 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.
Additional Information
* Unlimited contract possible.
* Remote work possible.
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