质量总监 / 中国区质量经理 / Quality Director - 负责中国区多家工厂
要求：
1. 熟悉化工或制药行业Overall质量管理经验
2. 熟悉质量体系 ISO90001，ISO19011
3. 团队管理经验 ，负责多家工厂经验加分
4. 英文口语流利
5. 有0-1新建工厂项目经验加分，有树脂产品经验加分
Quality Control
1.Responsible for all quality control laboratory supervisors, leads, and technicians.
2.Is accountable for all incoming, in-progress and final product testing.
3.Monitors and communicates non-conformances to department supervisors and senior managers.
4.Ensures adequate staffing and resourcing for all functions within the department.
5.Recommends measures to improve methods, quality of product.
6.Recommends and implements changes in working conditions and use of equipment to increase efficiency of the department.
7.Assists company representatives in quality matters.
8.Supervises and maintains all lab instrumentation – including PM and calibration schedules.
9.Prepares and distributes precise and timely reports as required.
10.Oversees maintenance of all quality control records and samples.
11.Interprets company policies to department workers and enforces safety regulations.
12.Performs other duties as assigned.
Quality Systems
13.Management Representative for manufacturing site Quality Management System (QMS).
14.Communicates all deviations and non-conformances to plant management and senior leadership as needed.
15.Works closely with global quality team.
16.Establishes and oversees internal audit process to ensure site is maintained in an audit ready state.
17.Communicates with authorities and customers, and coordinates the planning and management of audits.
18.Analyzes and approves general and operating procedures, work instructions and other quality-related documents.
19.Develops and maintains site quality metrics and ensures compliance and identification of trends leading to site/process/product improvements.
20.Reviews and approves validation protocols and reports.
21.Ensures that quality-related complaints are investigated and resolved as required.
22.Oversees process for reviews of completed batch production and laboratory control records of critical process steps before release of the products for distribution.
23.Releases or rejects all products. Releases or rejects intermediates for use outside the control of the manufacturing company. Establishes a system to release or reject raw materials, intermediates, packaging, and labeling materials.
24.Ensures a robust stability program supporting product, raw materials, QC Reagents and sets retest/expiry dates and storage conditions where appropriate.
25.Ensures adherence to professional standards and ethics.
26.Provides ad-hoc reports for senior management as required.
27.Performs other duties as assigned.
Educational and Experience Requirements:
1.Bachelor of Science in Chemistry, Chemical Engineering, Biology, or another relevant scientific field. Advanced degree preferred.
2.Minimum seven years Quality (QA and/or QC) experience required, with at least three years at a supervisory or manager level.
3.Must have hands-on analytical laboratory experience, knowledge of commissioning, qualification, and verification (CQV) process, and experience with performing and hosting audits from regulators and customers.
4.Minimum three years’ experience in Quality Systems Management.