The U.S. Pharmacopeial Convention (USP) Auditing Manager in Shanghai, China
Roles and Responsibilities:
GMP Auditing and Analytical Testing:
Reviews pre-audit information submitted by VER participants and makes recommendations on the participant’s readiness for a formal audit.
Conducts cGMP site audits of active pharmaceutical ingredient (API), excipient, and dietary ingredient and dietary supplement manufacturing sites, according to the appropriate cGMP guidelines and VER program requirements.
Acts as an interpreter for USP VER during audits and ensures that translations performed by Chinese participating companies (both written and verbal) are accurately recorded.
Creates audit reports in a timely manner summarizing the results of the site audits and makes recommendations regarding site compliance with cGMP requirements.
Where contract auditors have been used, reviews submitted reports and makes final recommendations regarding site compliance with cGMP.
Conducts site audits of contract testing laboratories, prepares audit reports in a timely manner and makes recommendations regarding laboratory compliance with VER requirements.
Reviews ingredient chemistry, manufacturing and control (CMC) or dietary supplement quality control manufacturing (QCM) documents submitted by VER participants.
Follows-up with VER participants for corrective action audit response and compliance with VER requirements, and provides a status report.
Prepares project plan or test protocol for samples under verification and obtains VER and/or USP’s Quality Assurance Group (QA) approval prior to its implementation.
Coordinate testing of Verification samples performed at contract testing labs in China.
Develops and updates VER SOPs, participant manuals, and other documents periodically in collaboration with QA and VER Staff.
Effectively assists chemists who conduct major analytical work by ensuring testing is carried out in accordance with the project plan.
Reviews and manages internal audit reports of VER participants and coordinates with VER to respond and initiate corrective action for audit findings.
Works closely with Strategic Custom Development team in China to develop new customers.
Works collaboratively with VER staff based at USP sites globally.
Coordinates with VER participants for surveillance testing and required documents as per VER requirements.
Completes requisition orders and expense reports for travel and materials related to VER activities.
Keeps track of time directly spent on VER project work and reports information on a monthly basis.
Provides support to USP-China supplier management, including database management, evaluation of critical/special suppliers, etc.
Performs other duties as assigned.
Education and Experience:
M.Sc. or Bachelor degree (or equivalent combination of education and experience) in the field of Chemistry, preferably synthetic organic chemistry, analytical chemistry, or other related field.
Minimum of eight (8) years of relevant experience working directly within cGMP facilities engaged in the manufacture and/or quality control/assurance of either bulk active pharmaceutical ingredients (APIs), excipients, and/or dietary ingredients and their finished dosage forms.
Knowledge, Skills and Abilities:
Should have extensive knowledge of FDA regulations pertaining to cGMP requirements, ISO 9001 and ISO 17025. A certificate from the American Society for Quality (ASQ) as a Certified Quality Auditor (CQA) is strongly desirable.
Working knowledge with International Conference on Harmonization (ICH) quality guidelines, and multidisciplinary guideline on the Common Technical Document (CTD) format for APIs is desirable.
Proficient with regulation and guideline interpretation, audit procedures, proper documentation, and QA and departmental policies and procedures.
Industry experience in the establishment of quality systems compliance is preferred. Knowledge of and experience with routine analytical methodologies is desirable.
Good organizational and planning skills; and excellent verbal and written communication skills (English and Chinese). Should be detail oriented; able to deal with multiple changing priorities; and able to work under minimal supervision.
Effective and efficient project management experience and CMC submission experience is preferred, especially CMC section authorship desirable.
Must be willing to travel approximately 40% domestically and internationally.
Job Category Quality Assurance
Job Type Full-Time