Senior Specialist Batch Record Review (m/w/d)

With over 15 years of experience in the classic pharmaceutical industry, biotechnology, chemistry and medical technology, we know the key contact persons who write out demanding tasks with potential. The high demand for personnel opens up exciting opportunities for dedicated professionals and managers to develop professionally and work on their own careers. As a specialized staff consultancy with an international network, we offer you decisive advantages - and this is completely free of charge for you. Register and benefit from interesting and matching positions and projects. About the company

Our customer Roche Diagnostics GmbH in Mannheim is one of the largest biotechnology centers in Europe, which, in addition to excellent positioning on the market, can demonstrate an exciting and committed work environment.

Processing of deviations incl. Impact Analysis, Root Cause Analysis and Deduction of CAPAs in Electronic System Veeva Planning, coordination and implementation of changes and CAPAs in the Veeva system Control of the filled HABs (also rebooking) on GMP-compliant documentation including tracking of timely correction by the responsible companies also in Electronic Batch Review systems Strict compliance with OLT (Order Lead Time) including tracking and requesting the required HAB accompanying documents such as IPC sheets, audit trails, trending and EMT reports Support for GMP audits e.g. by participation in the War-Room Support for actions on inspections or deviations(e.g. HAB searches in the archive) revision and creation of documentation-relevant SOPs in consultation with the supervisor and execution of training on documentation-relevant SOPs or HEA changes in agreement with the supervisor and the operation Implementation of own process optimizations in general support of operations units to improve good documentation practice and continuous error reduction (recognise bug trends and return to modules) Support in the introduction of new EBR systems after consultation of resources with the supervisor

Complete Bachelor Program in Biotechnology or Comparative Study Found professional experience in Parenteralia production Experience in processing deviations Good knowledge of GMP regulations and GMP-compliant documentation as well as hygiene knowledge in the pharmaceutical field Funded IT system knowledge (MES, SAP, Excel, Word) Good communication and team skills, organizational skills, sense of responsibility and process knowledge Clear written and oral expression in German as well as good oral and written English skills

Care in the entire application process A renowned company with excellent reputation Individual all-round assignment, support in the complete application phase Annual holiday entitlement of 30 days Above-average employee acquisition employee premium JOBV1_EN