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(Sr./Principal) Associate-QA Material
1.3-2万·17薪
人 · 本科 · 3年及以上工作经验 · 性别不限2024/11/28发布

苏州工业园区

低价好房出租>>

礼来苏州制药有限公司(湖东分公司)

公司信息
苏州木兰隽商贸有限公司

民营

该公司所有职位
职位描述
Responsibilities:
1.0202 02Be responsible for materials releasing.Make sure the quality of incoming materials is compliant to specification requirement
2.0202 02Specification maintenance andmanagement
3.0202 02Be responsible for establishing and implementing material supplier management program
61Establish and maintain supply management program to meet requirements of GQS and China GMP.
61Implement supply management activities according to supply management program,
61including but not limited to risk assessment, periodic quality evaluation, document/record maintenance, deviation and complaint handling and change assessment, etc.Responsible for preparation, maintenance and updating supplier quality agreement (except for imported semi-finished product) for incoming material.
61 02Assist procurement team to develop new supplier according to supplier development plan.
4.0202 02Be responsible for management of GMP service providers.
Manage the entire provider program (risk assessment, change control, prepare approved vendor list, providers periodic quality review, quality agreement, maintain the records and documentation in GMP Library, etc.)
61Develop GMP service provider management plan, initiate new providers according to
scheduled plan, and maintain qualified status of existed providers.
61To coordinate audits at the providers according to global audit team plan, perform
evaluation, having the authority to recommend the approval or rejection of the providers based on the applicable acceptance criteria.
61Responsible for the complaint of vendor and follow up response and action. Perform periodic visit for providers.
61 Communicate with providers effectively.
5.0202 02GQS implementation and improvement in quality systems.
6.0202 02QM representative for site SAP system.
7.0202 02To take part in the GMP audit for compliance.
8.0202 02Lead or support deviation investigation, change.
Requirements
61Bachelor’s degree or above02
61Capable of speaking, writing and reading English fluently
61Understanding of Good Manufacturing Practices, with previous experience in Pharmaceutical production or QA
61Strong organization skills and the demonstrated ability to develop a plan and drive the timely execution.
61Inter-personal skills including working multi-nationally and communicating proactively.02
61Ability for some business trips

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