MAJOR AREAS OF RESPONSIBILITY:

- Perform on site oversight of manufacturing and quality control testing performed by XingImaging’s subcontracted manufacturing organizations. Track and report to management any deviations from procedures.

-Participate in the on-site conduction of investigations related to non-conformance events.

-Issue and review daily production batch records.

-Review and approve requalification/calibration reports and certificates

-Participate in the development and approval of necessary documentation for the manufacturing of radiopharmaceuticals at the CMO (master batch record, testing standard, validation plan, SOP, WID)

-Participate in the oversight of document control systems to assure all
essential documents (batch records, Excel spreadsheets, SOPs) are accurately controlled and distributed properly to XingImaging’s subcontracted
manufacturing organizations.

- Ensure proper and timely implementation of corrective/preventative actions by XingImaging’s subcontracted manufacturing organizations.

- Ensure XingImaging’s subcontracted manufacturing organizations follow the instructions included in provided protocols when conducting validation activities. Review CMO validation raw data (analytical and process) for accuracy and integrity.

- Contribute to the completion and filing of training documentation, certification and licenses for XingImaging’s subcontracted manufacturing organizations employees.

- Other tasks as assigned by supervisor.

QUALIFICATIONS AND REQUIREMENTS:
- Minimum of Bachelor’s degree in science related field
- 1-2 Years experience working in a GMP environment
- Good knowledge of radiopharmaceutical regulation
- good English skills, both oral and written.