QA Manager-制药行业 Responsibilities:
In charge site quality control, quality system management.
Set up the company quality goal and regularly review the status of quality target. Train and guide the team to reach functional quality goal.
Manage engineers and inspectors team of QA section, coordinate with other dept./team.
Define the quality assurance policy and process, lead the implementation of quality assurance models and system that can guarantee to the organization customer satisfaction, continuous improvement and organizational effectiveness in order to achieve maximum competitiveness.
Prepare weekly and monthly quality reports, make continuous quality improvement through good team work
Connect customer needs with the conditions of the production process and define product guidelines and criteria and the conditions of the manufacturing process.
Quality management system implement, monitor and maintain. Conduct regular internal quality audits to ensure its effectiveness and suitability.
Ensure that the Quality Management System (QMS) is effectively established, implemented and maintained to be in compliance with ISO9001, ISO13485, 21 CFR 820, CE Standards and Chinese GMP.
Manage all inspection instrument, inspection gages, and test fixtures/tooling/equipment.
Requirement:
10+ quality management experience,5+ site quality control experience in pharmaceutical, IVD or medical device industry
People management experience
Experienced in ISO 13485, 21 CFR 820,GMP,QSR
FDA inspection experience
Sound knowledge in process quality control and risk management
Strong in leadership
Good at communication, coordination
Fluent in English
Responsibilities:
In charge site quality control, quality system management.
Set up the company quality goal and regularly review the status of quality target. Train and guide the team to reach functional quality goal.
Manage engineers and inspectors team of QA section, coordinate with other dept./team.
Define the quality assurance policy and process, lead the implementation of quality assurance models and system that can guarantee to the organization customer satisfaction, continuous improvement and organizational effectiveness in order to achieve maximum competitiveness.
Prepare weekly and monthly quality reports, make continuous quality improvement through good team work
Connect customer needs with the conditions of the production process and define product guidelines and criteria and the conditions of the manufacturing process.
Quality management system implement, monitor and maintain. Conduct regular internal quality audits to ensure its effectiveness and suitability.
Ensure that the Quality Management System (QMS) is effectively established, implemented and maintained to be in compliance with ISO9001, ISO13485, 21 CFR 820, CE Standards and Chinese GMP.
Manage all inspection instrument, inspection gages, and test fixtures/tooling/equipment.
Requirement:
10+ quality management experience,5+ site quality control experience in pharmaceutical, IVD or medical device industry
People management experience
Experienced in ISO 13485, 21 CFR 820,GMP,QSR
FDA inspection experience
Sound knowledge in process quality control and risk management
Strong in leadership
Good at communication, coordination
Fluent in English
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