Quality Management Representative (f/m) Sanaplasma – Czech Republic

Sanaplasma s.r.o. was recently acquired by Takeda, a leading global biotechnology company, and will operate as part of the Takeda BioLife plasma center division. As Quality Management Representative you will be responsible for leading the entire quality management process in the dedicated plasma centers. Your geographical area of responsibility will depend on your location and the plasma center clusters possible for Sanaplasma.

• Close collaboration with the Center Management Team, e.g. organize and conduct the local management review meeting in the plasma center including the necessary documentation
• Control the material flow in the plasma center, e.g. approval of production material before usage and approve and control the plasma shipment
• Preparation of management information, monthly reports and statistics, e.g. CAPAs, donor adverse events, epidemiological data, training
• Proceed with incidents, deviations and customer complaints
• Administration of quality documents
• Support the Risk Management process
• Surveillance of the hygienic situation in the plasma center
• Train and assure data integrity, data protection and security
• Perform GMP and EHS Walks on a regular basis
• Support internal, regulatory and supplier inspections
• Support the validation and calibration process (preparation of documents)
• Support projects for process improvements (Kaizen)

• Education in natural sciences (e.g. medicine, chemistry, biologics, medical care)
• Experience in Quality Management desirable, ideally in a plasma sourcing business or a pharmaceutical/ chemical company
• Knowledge on operational, quality or regulatory responsibility as well as legal requirements in plasma sourcing business in the Czech Republic
• Knowledge about GMP, GDP and Environment, Health and Safety
• Fluent in Czech, good command of English and/ or German
• Strong communication skills
• Good at working with people of diverse backgrounds
• Strong quality and service orientation
• Very good knowledge of MS Office
• Teamplayer
• Willingness to travel (you will be responsible for 3-4 plasma centers in your region in the Czech Republic)

As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees – our biggest asset – who enjoy a range of benefits and career opportunities, such as trainee and training programs, work-life balance, etc.

We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success.

We are looking forward to your application – please send your CV and motivation letter in English or German to Martina Kralikova ([email protected]).