Assoc Mgr, Quality

Job description

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Responsible for the daily operation monitoring of third-party warehouses and guiding them to comply with relevant regulations and Baxter requirements; undefined 2. Execute the product freezing process initiated by the headquarters or locally, including: Freeze initiated by the headquarters: After receiving the freeze notification from the headquarters, relevant processes will be executed on the headquarters freeze system as needed, including confirming the impact, entering inventory, completing the disposal plan, etc. Locally initiated freezing: After identifying local product freezing needs, execute local product freezing procedures, including initiating, disposing and closing product freezing applications, perform relevant operations on the local system, save relevant records, and notify relevant parties who may be affected Departments, such as supply chain and business units. 3. Responsible for the disposal of unqualified/problem products, including: Conduct on-site inspections of unqualified/problematic products (including returned products), give written opinions and signatures according to internal process requirements, and complete system status adjustments. Effectively supervise the subsequent processing process to ensure that relevant records and vouchers are saved as required. For products with a near-validity period, system status adjustments shall be completed regularly according to internal process requirements. undefined 4. Responsible for the execution of first-camp audits to ensure compliance with relevant laws and regulations and internal process requirements, including: Responsible for the first marketing review and release of products. If any discrepancies are discovered in the product, responsible for initiating deviation/CAPA or other internal applicable procedures to ensure that all risks are controlled before release. And ensure that product-related quality information is collected and updated in a timely manner, and establish quality files and catalog lists; Responsible for the review, approval and daily maintenance of suppliers' legal qualifications (including but not limited to products, services, third-party logistics, transportation carriers), and conduct on-site audits when necessary to ensure compliance with relevant laws and regulations and internal process requirements; Responsible for the review, approval and daily maintenance of suppliers’ legal qualifications. undefined 5. Responsible for the local implementation and changes of product Chinese labels and Chinese instructions to ensure compliance with relevant regulations and internal process requirements; Responsible for the local implementation of internal and external audits, including: Ensure timely notification of external audits (including inspections by regulatory agencies) and headquarters audit information, track and ensure that all deficiencies are closed within the time limit as required; Develop an internal audit plan and assist relevant functional departments to complete it as planned, track defective items and ensure that defective items are closed in a timely manner. Properly preserve documents/records related to internal audits. Responsible for the localization management of quality management system documents, including: Organize the local implementation of headquarters documents and ensure that the relevant document change process is well executed and controlled; Responsible for maintaining the documents of the local organization, ensuring that the drafting, review, issuance and effectiveness of documents are carried out in accordance with the requirements of relevant regulations and internal processes, and managed in the document system; Responsible for the guidance and supervision of the execution of headquarters documents/local documents, and inspecting the implementation. Track the distribution of relevant training in the training system after the document is released. Responsible for the implementation of deviation management and CAPA processes within the organization, running system reports in a timely manner, promoting the good implementation of deviation management and CAPA and meeting time limit requirements; initiating deviations and/or CAPA if necessary; Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. 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