QA Supervisor/Manager 品保主管
● Evaluate, recommend, plan, implement, and maintain strong practice
standards for company R&D and GMP activities
● Provide guidance, review, and approve R&D and manufacturing protocols,
batch records, and QC SOPs
● Review and approve protocols, reports, and deviations as it relates to
validation and manufacturing activities.
● Plan, schedule, conduct, and report external audits and inspections
globally or domestically as needed.
● Establish Quality Agreements with CRO and CMO providers.
● Communicate Quality and audit findings with appropriate personnel;
establish and implement action plans (CAPA), Change Control, and
Deviation reports when required