Pfizer PGS QO Leader in Wuxi, China
Participate in strategic planning activities and transmit strategic decisions into operational plans. Prepare departmental budgets and control the departmental cost within the budgets. Organize the purchase of capital projects and analysis instruments according to Pfizer policies and actual situation of PGM Dalian/Wuxi. Direct comprehensive quality operation to insist on continuous improvement Ensure that all Pfizer policies or PQS and all Technical & Quality documents are timely received and distributed to related departments via Pfizer Document System. To set up a series of Laboratory Procedures in compliance with Pfizer Policy guidelines and requirements in PQS, at the same time endure that it meets the Chinese regulations, approve each Laboratory Procedure issued. Ensure testing and releasing for the API and excipients meet production plan. Developing, implementing and maintaining Quality Assurance System to ensure that plant manufacturing practice is compliant with both local regulatory and Pfizer Quality requirements. Ensure the registration effectiveness of materials. To approve the release of products manufactured in Wuxi site. Approve the GMP document of Wuxi site. According to PQS and GMP， combine Wuxi site actual situation to organize effective quality risk management. Organize regular internal and external Quality Audits in accordance with local and Pfizer policy. And follow-up the implementation of corrective action.
Coordinate and be responsible for the external audit to Wuxi Site. Follow-up corrective action in Wuxi Site and improve Wuxi quality management system.
Work closely with Wuxi site leadership team to facilitate corporate goals and objectives. Be concerned with new trends in pharmaceutical industry. When necessary implement adaptation and improvement of quality management in Wuxi site.
To keep good and effective communication with suppliers and Pfizer network so as to improve quality management.
To keep good and effective communication with government to have sufficient comprehension of the regulations.
Provide guidance and tools to support teams or departments to meet the objective.
Provide guidance to improve the staffs' ability outside the work area.
Work closely with reporting supervisors to ensure the effectiveness of training and development of department staff.
Ensure all staff in the plant is adequately trained on GMP concept and make department staff have enough training for their job.
EHS management of the department.
Perform the responsibilities of Quality Manager regulated in China GMP.
Perform the responsibilities of Quality lead defined in the Site Quality lead standard work.
Other work committed by Operation Director and PGS EM China QOL.
C:Plant Clock Standard - 标准工时制 (China)
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