Responsibility:
- Responsible for Quality Management System (QMS) compliance. Management of all company-wide, quality polices, procedures, processes, programs, and practices, to assure the company of continuous conformance, with appropriate standards and country regulations to ISO 13584:2016, GDP, ICH-GCP and GMP.
- Champion, support or lead quality improvement initiatives.
- Establish and manage procedure for accurate, effective and timely operation (Quality Agreement, Risk Assessment, etc)
- Acts as liaison officer to the certifying boday and regulatory on matters relating to the Quality Management System.
- Develop programme for Quality training by establishing a training programme for the company comprising of ISO, GMP, GDP, and Compliance trainings.
- Formulate and administer policies and standard operating procedures relating to the QA/ QC functions as well as the Quality Management System.
- Provide QA/QC input and guidance with the remediation of major quality issues. Review, evaluate and support proposed corrective and preventive action plans (CAPA) in collaboration with the responsible Depot.
Requirements:
- A degree in science or equivalent (preferably licensed pharmacist).
- Minimum of 5 years of industry experience and 3 years of QA experience, experience clinical trials will be an advantage.
- Proficient in QA procedures and familiar with relevant GMP, GSP/ GDP, ICH GCP and, preferably, GLP and ISO standards. Knowledge of international regulations an advantage.
- Ability and willingness to travel (international and domestic).
Song Zhaohui EA License No. 02C3423 Personnel Registration No. R1761205
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