工作职责 Responsible for release of raw material, packaging material and imported bulk. Responsible for approve Technical Registration Dossier of raw material, packaging material and imported bulk. Manage all quality processes in SAP, responsible for optimize the processes in SAP and make sure to comply with GMP requirements and other quality requirements, lead all SAP QM related issues as SAP QM key user, communicate and solve quality relevant issues in SAP with headquarters, other Bayer plants and other departments in Beijing. Lead the work of SAP QM quality master data management. On behalf of Quality director to approve SAP change relevant documents as local QA. On behalf of Quality director to approve all SAP material master data related to quality. On behalf of Quality director to approve the authorization of QM in SAP. Responsible for GxP evaluation of computerized system and other Quality responsible tasks related to computerized system validation. Establish and revise all related SOPs according to global documents and authority requirements, for all GxP relevant computerized systems in Beijing site (including in Quality, Warehouse, Production, etc.), responsible to approve all Quality related validation documents, including GxP Evaluation, URS, Risk Assessment, UAT, Validation Protocol, Validation Report, etc. Lead internal and/or external audit on IT system to guarantee the quality assurance system in compliance with cGMP, international/local regulation, etc.. For the vendor provided GxP relevant IT system to Beijing site, lead the external audit. In Beijing site, responsible for internal inspection of GxP relevant computerized system. Responsible for Data Integrity issues. For all GxP relevant computerized systems in Beijing site (including in Quality, Warehouse, Production, etc.), lead the implementation and approve the relevant documents of  Data Integrity assessment and remediation completion in all relevant departments.  任职要求 Education: Bachelor degree of Pharmaceutical science or related. Total more than 8 years' experience in the pharmaceutical company. More than 5 years' experience in the field of QA. More than 3 years' experience of material release and SAP QM management. More than 2 years' experience of computerized system validation. Know the knowledge of computerized system validation, Data integrity, SAP QM, TRD and quality release procedure, IT audit. Know Chinese GMP and EU GMP., have good GMP concept. Good communication, presentation and interpersonal skills. Familiar with MS Software including Word，Excel，PowerPoint. Fluent in English speaking and writing. Strong organizational, analytical and troubleshooting skill 职能类别：药品生产/质量管理