Daiichi Sankyo Europe GmbH | Germany | 85xxx Pfaffenhofen an der Ilm | Permanent position | Full time | Published since: 13.05.2026 on stepstone.de
Expert QA Operations - Operational Technology (OT) Oversight (m/f/d)
At Daiichi Sankyo we are united behind a single goal: to improve life around the world through innovative medicines. With active innovation since 1899, presence in more than 30 countries and over 19,000 employees, we develop groundbreaking therapies in oncology, cardiovascular diseases, rare diseases and immune diseases. In line with our vision 2030, "to be an innovative global healthcare company that contributes to the sustainable development of society," we create a healthier, hopeful future for patients, their families and society. Expert QA Operations (m/w/d) - Operational Technology (OT) From now on, we are looking for a dedicated person for our location in Pfaffenhofen an der Ilm, who supports our QA Operations team in ensuring compliance with regulatory requirements, internal instructions and the requirements for Operational Technology (OT) and computer-assisted systems and also contributes to the qualification and validation of the associated systems. .
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Your tasks • Your profile • What we offer
Responsible for QA Oversight of Operational Technology (OT) related infrastructure and software QA Oversight in the validation of software and computer-assisted systems according to current guidelines (EU GMP Annex 11 or Annex 15, 21 CFR Part 11, GAMP5) Examination and approval of validation and qualification documents such as URS, risk analyses, validation or Qualification plans/reports, test documents, traceability matrices in OT and computer-assisted systems Monitoring and participation in the qualification/validation conversion and subsequent ensuring the maintenance of the qualified/validated state Evaluation of amendments to ensure a GxP-compliant implementation of changes in OT and computerised systems Evaluation of deviations to ensure a validated/qualified state in the field of OT and computerised systems Support in the creation or revision of work instructions Preparing documents and supporting government inspections Contact persons for authorities' inspections on issues relating to the area of responsibility Interface to the global IT department and global IT systems such as eQMS, ServiceNow and SAP, which affect the area of responsibility Contact for e.g. OT, IT, Production, Quality Control, Process Development, Engineering, Plant Administration for topics relating to the area of responsibility
Completed scientific studies or comparable training Multiannual practical OT experience in GMP-regulated environment within QA Knowledge of relevant national and international rules and laws Independent and conscientious operation Reliability, Carefulness, Quick Opinion, Responsibility and Teamability (also interdisciplinary) Good knowledge of German and English in word and writing Good knowledge of digital systems
Attractive Benefits Work-life balance Personal growth and development Health and well-being
Location
 | Daiichi Sankyo Europe GmbH | |
| 85276 Pfaffenhofen an der Ilm | ||
| Germany |
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