【岗位职责】
Support QA team to build up quality management system. Ensure site can meet all Customer & Merck quality requirements. ➢Responsible for sourcing and updating new regulatory and new Merck Life Science requirements into site.
➢Transfer the technical documents from different giving sites to Merck Life Science Nantong.
➢Responsible for shop floor inspection and control for the whole production process to ensure the whole production process control to be in compliance with site procedures.
➢Participate the management of routine quality affairs: including the handling of deviations, change control complaints and investigation of other quality issues
➢SOP tracking, e.g. SOP update status, SOP training status, including cross-function status tracing.
➢ To organize and coordinate electronic Quality system related works, such as Mango, Trackwise, SAP and so on.
➢Issue controlled documents to using department, and document issuance record in a timely manner.
➢Review quality controlled documents, e.g. batch manufacturing records, packaging records and associated documentation in support of batch disposition.
➢Comply with corporate and site safety procedures.
➢Complete other QA related work assigned by QA manager.
【任职要求】
➢English reading and understanding are mandatory, English speaking is preferred.
➢Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook and PowerPoint)
➢To be cooperative and have sense of responsibility.
➢Good Learning ability, good communication skill and cross function work ability.
➢Bachelor's degree or above (211, 985 is preferred).
➢Related major of Pharmaceutical, Chemistry, Food, Microbiology, Biochemistry etc. Chemistry or Pharmaceutical is preferred)
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