工作职责:

Responsibilities:

? Work with the lead QA management to define the strategy for quality management in WuXi AppTec Co., Ltd. GLP Laboratories including process reengineering or continuous process improvement and quality training.

? Support the development and implementation of a WuXi AppTec Co., Ltd. GLP-wide quality system and Quality Management System (QMS)

? Participate in the expansion of GLP principles and international laboratory quality standards (e.g. GCP) to other laboratory areas in WuXi AppTec Co., Ltd. as requested.

? Participate in communication with all levels of laboratory personnel and line management on purpose, direction, and goals of quality management.

? Review and approve QA regulatory documents when required.

? Conduct and report QA activities in support of BU regulatory activities, i.e., study inspections/audits, vendor audits, and facility inspections

? Assure regulatory authority inspections are fully supported

? Provide input to GLP QA Shanghai SOPs, and BU Operational SOPs

? Ensure consistent inspection practices of GLP QA operations within China

? Assume the responsibilities and role of GLP QA Senior Director when delegated.

? Monitor local projects so that work is on course to meet regulatory or client submission dates

? Oversee local QA work prioritization and resource management

? Provide local QA groups with general direction and guidance.

任职资格:

Qualifications:

? Degree in Science or related experience

? At least 5 years experience in the quality assurance monitoring of Bioanalytical (LC-MS/MS and ELISA) in research & development and production environments.

? Understanding of Quality systems and global regulatory (GLP) requirements

? Strong communication and negotiation skills

? Excellent interpersonal and leadership skills

? Excellent communication, both written and oral, in English and Mandarin

Preferred:

? Good English skills

? Proactive compliance philosophy

? Organization skills

? Significant prior experience in GLP QA

上班地址：上海市外高桥保税区富特中路288号