Job CSV/EQ Specialist (GG29) Burgwedel (30938), Germany - Aplitrak

CSV/EQ Specialist (GG29) Burgwedel (30938), Germany

We are looking for an experienced CSV/EQ Specialist on a 6 month contract to join a dynamic and busy international team based in Burgwedel, Germany.

Implementation of computer system validation (CSV) for software such as process equipment (SCADA system), building services, analysis equipment within production and quality control, validation of Excel sheets
Implementation of equipment qualification for production equipment and analyzers
Adjustment of global regulations and transfer to local procedures. Working with global software tools (such as change management, training, deviations)
Independent coordination of appointments and availability of equipment with other departments at the site, close cooperation with the IT department
Responsible for the creation, revision and approval of GMP-relevant documents (qualification documents, SOPs) in Dutch/English
Preparation of documents for official inspections and presentation in the audit (Dutch and English)

You have completed a technical degree at the university / college or you have completed technical vocational training and professional experience in the qualification / validation area of the pharmaceutical industry
Sound knowledge of qualification and CSV as well as GMP fair documentation
Good knowledge of MS Office applications (Word, Excel, PowerPoint)
Willingness to become familiar with various software applications.
Dutch fluent in spoken and written and good English language skills
They ensure regular work processes, plan systematically and organize their own area of responsibility efficiently
You work effectively with others, share necessary information, share your knowledge, and contribute to achieving team goals through your work
You work on essential tasks, finish what you start and you do not give up easily even when obstacles

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