Quality Assurance Assistant Manager

Main Responsibilities / Key Responsibilities:

1. Responsible for reviewing draft SOPs before approval.

2. Draft/revise DSC SOP

3. Review study plans & related amendments, audit critical phases of studies, audit raw data and study reports & related amendments, and issue QA statement.

4. Conduct facility audits and computerized system audits as appropriate and evaluate GLP compliance.

5. Responsible for reporting critical GLP deviations to Test Facility Management in a timely manner and report deviation in QAU to QAU lead in a timely manner.

6. Provide GLP trainings, SOP trainings, quality trainings, QA skill trainings to DSC staff.

7. Advise & review the validation/qualification, operation, maintenance, and retirement activities of computerized systems and IT infrastructure.

8. Execute external audits on CROs, suppliers and vendors as appropriate.

9. Maintain and archive QA records.

10. Support the respective country or organization's regulatory department and customers' audits. Act as support during visits/inspections by clients and local and global authorities.

11. Take any other responsibilities of QA that required by DSC SOPs, like follow up and manage CAPA, and draft,review, and follow up Quality Improvement Plan (QIP).

Work requirements / Job Position Requirements:

1. Bachelor's degree or above, with drug development, pharmaceutical, biology, medicine, and/or chemistry work experience or training. BS, MS or Ph.D.; work experience or training in drug development, pharmaceutical, biology, medicine, and/or chemistry.

2. Familiar with OECD, US FDA, NMPA (CFDA) GLP principles/regulations.

3. Have good communication skills and be able to work in a team-oriented manner to achieve department objectives.

4. Familiar with business processes, e.g., drug development.

5. English listening, writing, speaking, and reading are fluent.

Additional Requirements/ Special Requirements: 1. Have some basic IT application knowledge Basic working knowledge of Information Technology.