Quality Assurance Engineer within the Experimental Therapies Center

Administration

Quality Assurance Engineer within the Experimental Therapies Center

The Experimental Therapies Center is looking for a Quality Assurance Engineer between 80% and 100%.

The Experimental Therapies Center represents the interface between fundamental research and clinical research. This key platform in the fight against cancer plays a fundamental role in the evolution of therapies offered to patients treated at CHUV, whose specific objective is to support the development of innovative therapies, particularly cellular therapies. Thus, to push the boundaries of therapies currently available to patients, our department places particular emphasis on its translational clinical research, which serves as the bridge between the laboratory and the patient's bedside.

Do you want to contribute to the success and performance of the CTE? Do you want to be part of a team of competent, motivated specialists who play a key role within our institution?

Then keep reading!

Context

The Lausanne University Hospital (CHUV) is one of the 5 Swiss university hospitals. Thanks to its collaboration with the Faculty of Biology and Medicine of the University of Lausanne and EPFL, CHUV plays a leading role in medical care, medical research, and education.

Our UNIL-CHUV oncology department brings together cancer clinic and research with an innovative spirit. It includes the medical oncology, radio-oncology, hematology services with the CHUV bone marrow transplantation activity, and the Experimental Therapies Center (CTE). It also integrates the Ludwig Center of the University of Lausanne for cancer research, particularly in the field of immunotherapy.

The medical oncology service at CHUV is currently the largest specialized platform in this field in Switzerland. Its mission is to manage, diagnostically and therapeutically, and ensure the follow-up of adult patients suffering from cancerous diseases and to offer each patient access to optimal personalized treatment, whether in routine practice or within clinical studies, taking into account all innovations and knowledge changes over time.

Mission

Within this mission, you will be responsible for:

• Ensuring quality monitoring of GxP operational activities to guarantee that delivered products are of appropriate quality, compliant with internal and external requirements, as well as regulatory requirements
• Reviewing and approving operational documents and records within the scope of GxP activities
• Providing QA support according to current procedures, related to management: of suppliers and materials, changes, deviations, CAPA, training, and document management
• Supervising the review of batch records before their release
• Actively participating in QA meetings as well as operational meetings of partners as QA referent and ensuring presence on site
• Assuming the role of Process Owner (PO) for QA processes: ensuring design, deployment, monitoring (KPI management), and continuous improvement of processes
• Participating in the preparation, conduct, and follow-up of regulatory audits/inspections
• Participating in the development and digitalization of quality processes

Profile

• You hold a Master’s degree in life sciences or pharmacy, engineering, or an equivalent qualification with significant experience in the manufacture of sterile injectable products
• You master EU GMP good manufacturing practices and the PIC/S GMP guide PE009
• You have at least 3 years of experience in a sterile GxP environment
• You demonstrate good command of English and French (spoken and written)
• You have good proficiency in common computer tools (Microsoft Office)
• You are rigorous, have an analytical mind as well as excellent organizational, writing, and interpersonal skills.

We offer

Becoming a collaborator at the Lausanne University Hospital means benefiting from:

• Top-tier social benefits, 20 days paternity leave, and 4 months maternity leave (with the possibility of an additional month of breastfeeding leave)
• Regular salary progression adapted to responsibilities
• A 13th salary and 25 days of vacation per year
• A right to a minimum of three training days per year, with access to a varied offer within the CHUV Training Center and partner training centers of the State of Vaud
• Facilitated access to one of the 500 furnished apartments offered in the surrounding neighborhoods for people relocating to Switzerland from abroad
• Social, cultural, and economic benefits offered to members of the H-Oxygène association
• Benefits offered within the mobility plan (discounts on public transport subscriptions, promotion of "Mobility" vehicles, and discounts on the purchase of electric bikes)
• Quality hotel-style company restaurants in each hospital building with preferential rates.

Contact and application submission

Contact for information about the position: Ms. Saïda Sabri, QA Operations Manager at: 079 556 09 39.

Since all our applications are processed electronically, we kindly ask you to apply exclusively online by clicking the APPLY button at the bottom of the announcement.

If you have difficulty applying, you can consult our procedure on how to apply online. If for technical reasons you cannot apply online, we invite you to contact our Recruitment Unit, which will assist you in your process, either by email at e.recrutement@chuv.ch or by phone at 021 314 85 70

CHUV applies the highest quality standards in its recruitment processes. Furthermore, committed to promoting diversity among our collaborators, we pay attention to different life paths and do everything possible to ensure equal treatment and avoid any discrimination. We look forward to receiving your application.

We kindly ask placement agencies to note that applications submitted directly by them on our recruitment platform are not accepted and cannot be invoiced. Thank you for your understanding.