Suzhou, Shanghai, China
41 days ago
(Sr./Principal) Associate-QA Material

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Responsibilities:
1.    Be responsible for materials releasing.

Make sure the quality of incoming materials

is compliant to specification requirement

2.    Specification maintenance and

management

3.    Be responsible for establishing and

implementing material supplier

management program

Establish and maintain supply management program to meet requirements of GQS and China GMP.Implement supply management activities according to supply management program, including 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. Assist procurement team to develop new supplier according to supplier development plan.

4.    Be 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.)Develop GMP service provider management plan, initiate new providers according to scheduled plan, and maintain qualified status of existed providers.To 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.Responsible for the complaint of vendor and follow up response and action. Perform periodic visit for providers.Communicate with providers effectively.

5.    GQS implementation and improvement in

quality systems.

6.    QM representative for site SAP system.
7.    To take part in the GMP audit for

compliance.
8.    Lead or support deviation investigation,

change.

Requirements
Bachelor’s degree or above 
Capable of speaking, writing and reading English fluently
Understanding of Good Manufacturing Practices, with previous experience in Pharmaceutical production or QA
Strong organization skills and the demonstrated ability to develop a plan and drive the timely execution.
Inter-personal skills including working multi-nationally and communicating proactively. 
Ability for some business trips
 

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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