We are seeking at the earliest opportunity a Specialist for Qualification of Computer Systems Kaluga (m/f).

Your duties:

• As part of our expansion strategy at a dynamically growing company, you will be involved in establishing a new production facility with over 150 staff at the Kaluga site in Russia. You will support us with your specialist knowledge and intercultural competence during the familiarisation phase in Berlin and then permanently on site in Kaluga.

• Your challenging work will focus, on the one hand, on the coordination and implementation of investments regarding laboratory equipment and computerised quality control systems. On the other hand, you will be responsible for the planning and administration of central IT systems and the management of master data with SAP.

• Moreover, you will function as the internal IT coordinator and supervise all IT-relevant projects and issues in the area of quality control. You will monitor the internal and external services provided for the qualification of units and software validations and support the change, configuration and documentation management. This will involve you guaranteeing adherence to valid legal and internal provisions as well as the requirements of the Russian federation.

• Along with the management of master data, you will be responsible for reconciling and drafting specification-compliant Testing Protocols in SAP. Furthermore, you will periodically test the GxP validation status of relevant quality control units and computerised systems and identify follow-up measures based on these.

Our requirements:

• Either a university degree in information technology or alternative information technology qualifications
• Several years' professional experience at a pharmaceutical company
• Several years' experience in the area of GMP regulations and the validation of computerised systems and knowledge of equipment qualification as well as in the area of IT
• Sound knowledge of the area of medicinal product testing
• Knowledge of SAP administration (laboratory, data and management system)
• Very good spoken and written Russian and English language skills
• Good German language skills
• High degree of dedication linked to with a structured working style
• Strong intercultural competence and experience
• Willingness to engage in international travel
• Good MS Office skills

Please send your full application and supporting documents in English.

We look forward to meeting you.

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