quality audit.

about the job.
Lead the establishment and maintenance of the quality system and ensure its compliance with applicable regulatory requirements；
Allocate resources and personnel to support and oversee the operations of Production, Engineering, Information and Digital, QC and Materials Management to ensure compliance with GMP requirements;
Review or approve quality activities such as investigations of deviations, OOS, complaints, returns, recalls, and corresponding CAPA activities according to established procedures;
Allocate resources and personnel to support CMC project operations to ensure compliance with GMP requirements and achievement of project schedule requirements;
Allocate resources and personnel for internal audits, regulatory agency inspections, client audits and third-party audits；
Responsible for the verification activities of the company's facilities, utilities, systems and APS in compliance with cGMP requirements; coordinate the completion of qualification and verification of facilities, utilities, systems and APS. Work with system owners and project teams to establish and maintain the validation status of directly impacting systems in compliance with Good Manufacturing Practices (GMP); Prepare and/or approve validation summary reports;
Generate, review and/or approve eligibility deviations and manage their closure by agreed dates;
Review factory acceptance and site acceptance testing (FAT and SAT) documents prepared by suppliers.

skills and experience required.
Bachelor degree or above, science and engineering majors preferred.
More than 8 years of working experience in the quality management industry. Applicants with experience in the pharmaceutical or medical device industry are preferred. Applicants with QA experience and regulatory submission experience in China are preferred;
8 years of GMP quality system QA work experience, NMPA, EMA or US FDA-licensed pharmaceutical company verification experience.
Have leadership experience in a team of more than 10 people;
Familiar with the operation and verification of aseptic filling systems and pharmaceutical utility systems;
Ability to analyze and summarize large amounts of information, including sound knowledge of statistical analysis, to prepare summary reports;
Excellent written English skills, preference will be given to candidates with excellent oral English skills.