- Manage SOPs and SOP deviation/waiver
- Support the development, maintenance, and/or continuous
improvement of Quality System (SOPs, work instructions, tools, templates,
etc.).
- Develop and deliver training programs and/or
materials
- Support QA auditors, as needed (i.e.
preparation, conduct, follow-up)
- Support with responsible parties to prepare
Corrective Action and Preventative Action (CAPA) plans as applicable
- Follow up the CAPA plans
- Support the auditors in the audit and vendor
assessment program
- Assist with relevant departments to
coordinate and manage regulatory inspections and Sponsor audits
- Support the QA report creation to see the
quality performance
- Support the preparation of quality committee
- Perform the contracted services to the
clients such as SOP development, training, advice for GCP
- Execute other duties as delegated
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