U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) Auditing Manager in Shanghai, China

Description

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.

Departmental Activities:

  • 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.

Minimum Requirements

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.

Supervisory Responsibilities:

None.

Job Category Quality Assurance

Job Type Full-Time

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