Provides functional hands-on quality supports to product complaint management at affiliate level to ensure that business and quality objectives are met.
Responsible for the support of analytical techniques for products in China, including IDC testing supports etc.; responsible for the investigation of quality events happened in Gilead China, quality investigations of quality issues for imported products and products in the market according to global and local procedures.
Responsible for quality-related regulatory intelligence and risk assessment.
Manage GMP/GSP related records, support and manage activities related to importation, internal and external quality audits, quality agreements, routine distributor visits, product market actions, training records etc.
Ensure all GMP/GSP documents (including SOPs/records in China affiliate) are maintained and revised in compliance with Gilead and local regulatory requirements.
Prepare and ensure quality reports including quality analysis/trends, quality documents/records and follow up the execution of action plan, etc.
Provide training support/management for all staffs at affiliate level.
Follow quality principles to ensure effective compliance of the affiliate quality system with Gilead policies, processes and procedures and all applicable regulations and industry standards, including creating and maintenance of local procedures, work instructions, records and all applicable quality system documents.
Participate in internal and external quality audits to support the launch and distribution of Gilead products in China.
Communicate with internal and external customers on all quality and compliance-related matters.
Assist the Affiliate Quality on project execution and administration, including: prepare Service/PO/Contract approval; document various aspects of the projects according to the project management procedures.
Ad-hoc tasks assigned by line manager.
Occasional trips to activities needed.
Qualifications
5+ years of relevant experience in the pharmaceutical industry. 2+ years of quality experience working at GMP manufacture site.
Bachelor's degree or above in pharmacy or a related field.
Good communication skill, expression ability and teamwork spirit.
