工作职责

 1. As QA shift supervisor to handle all quality issues during the
 shift, clarify the problem and investigate the root cause together with
 the shift supervisors/managers of production, Engineer and warehouse,
 then make the decision for immediate actions as soon as possible, not
 only ensure the product quality, but also need to consider the
 production efficiency; then find the corrective and preventive actions
 and discuss them with the supervisor of the related departments, push
 the staff to follow the actions and monitor to ensure the production
 smooth running in compliance with GMP requirement.
 2. As QA shift supervisor to organize the team member to review batch
 record and inspect the sample in time, monitor the release status of
 every batch, investigate the issues to release the product on time to
 ensure plant smooth running, inventory safety and market supply.
 3. As the authorized release person to make decision to release/reject
 everybatch the locally manufactured and packaged products, not only
 check all important information on the batch documents, the quality of
 the samples and test results, but also confirm the investigation for
 the issue is clear or not, the actions forthe issues is enough or not,
 to ensure all released products comply with Bayer global & local
 registered specifications and local GMP regulation, no risk to the
 patients, no recall.
 4. As the authorized release person to make decision to release/reject
 packaging materials according to the purchasing and testing
 specification and 100% ensure only qualified material can be released
 to ensure the product quality.
 5. As the plant leader of quality-bridge project to lead all related
department heads/supervisor of the whole plant to evaluate the quality
 level, analysis reasons with the related departments, discuss the
 actions, report them to the management team to get the approval, then
 follow up the actions and push them tobe implemented to keep the good
 quality level of the plant.
 6. Perform the annual product quality review, review and check the
 quality level of related product; if the weakness is found, need to
 investigate the root cause and align the actions with production
 supervisor, follow up and push the actions to improve the quality of
 this product.
 7. Lead oversight and knowledge of what happens at the shop floor to
 ensure that appropriate shop floor oversight is practically organized.
8. Create/revise GMP related SOPs according to new requirements and
 directives, including design and check the operation procedures to
 ensure the procedures is reasonable and compliable, make the operation
 procedures to follow easily, and monitor the procedures to be followed
 strictly to ensure the product quality and GMP compliance.
 

任职要求
 1. Education: Bachelor degree of Pharmaceutical science or related.
 2. Experience:
 ？ Total more than 7 years experience in the pharmaceutical company.
 ？ More than 5 year experience in the field of QA.
 ？ More than 1 year experience in release product and handling
 deviation.
 3. Knowledge & Skills:
 ？ Familiar with product release
 ？ Familiar with production process and equipment, operation procedure
 ？ Familiar with Chinese GMP and EU GMP.
 ？ Good communication, presentation and interpersonal skills.
 ？ Familiar with office Sof