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- Quality Assurance associate is responsible for control of qualified product's release to local market in compliant with local on imported pharmaceutical products with satisfying internal and external global requirements. ACCOUNTABILITIES:
- Making sure for local QC test to be timely prepared and performed for seamless product supply by communicating with manufacturing site, supply chain, contract laboratory, warehouse etc.
- Perform the release of product with preparation of summary protocol etc., as Quality Pharmacist Personnel
- Pre-evaluation and set up of pre-requisite of NDA product QC test and release on timely manner
- Communication and transfer of rational document for local QC test to contract vendor and support
- Plan and import the reference standards and reagents for local QC tests, with continuous monitoring on its inventory status
- Obtain HA approval for non registered drug product importation for pre-evaluation QC test and obtain KCMA approval for reference material importation for QC test
- QA SOP preparation and its implementation according to Takeda Quality Management System and local regulation.
- Document management and archive relevant documents to meet the Korea drug importer requirement.
- Support HA inspection regarding quality issue, self inspection, CAPA, Change control, annual product review, etc.
- Product quality related deviation, change control handling with its follow up by CAPA
- Support supplier management operation, including GMP/GDP supplier qualification and audit.
- Evaluate external vendor's validation documents or perform relevant validation.
- Find and fill the gap between local practice and current internal and external requirements for GMP/GDP area and improve local quality management system continuously.
- Duties and / or roles are not limited to details above and may evolve or change during the course of the role based on company priorities and manager's discretion EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- More than 4 yrs of related work experience is required
- Major in Pharmacy or similar (Mandatory: Valid pharmacist license) TYPE: Regular employee Locations KOR - Seoul Worker Type Employee Worker Sub-Type Regular Time Type Full time
Quality Assurance Associate, Seoul, Korea - Takeda
설명
Description
OBJECTIVE: