MNC Medical Pharma Company
Duties
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Responsibilities To be responsible for collecting, categorizing and analysing quality data from vendors, products, quality system, authority, standard to support company quality metrics. This role report to Associate Quality Director to support the investigations, internal audits, and CAPA implementation and monitoring.
Product Complaints Handling
- Being the coordinator between global QA and customers to ensure timely reporting and investigation result delivered.
- Implement and manage counterfeit identification
- Follow up return sample status and investigation status.
- Translate investigation report.
Testing and 3rd party lab management
- Manage testing in 3rd party labs, ensure timely completion of the experiment.
Customer and Vendor qualification management
- Customer qualification check and approval in system
- Ensure quality agreements established with LSO and distributors.
- Audit LSO warehouse to ensure quality agreement has been implemented.
Support authority inspection and internal audit and undertake introduction training and refresher training related to QMS for local affiliate staff.
Support documentation including create, renew, review, isolation;
Participate in the creation/update of local SOPs to reflect local practices in accordance with Corporate Policies and SOPs or updated regulations.
Collecting, maintenance, analysis and reporting of Quality data and KPIs.
Support other relevant quality department work.
