[ROLES]
1.Third Party Management
1) Align direction with APAC-TPO team in managing Third Party Contractors (TPCs) associated with Korea sites based on risk-mapping score.
2) Act as the point of contact for quality-related issues and/or quality improvement plans for TPCs associated with Korea sites.
3) Monitor KPI of each TPC.
4) Batch Review for release of products manufactured by TPCs.
5) Review Change Requests received from TPCs and proceed the Change Control.
6) Review key Deviations/OOSs proposed actions including assessing risks prior to allowing CMOs to continue operations and/or releasing products to markets.
7) Maintain Imported Product Management records.
8) Support transfer of technology to TPCs and outsourced laboratories.
9) Remain abreast with cGMP and local regulatory requirements relating to products.
10) Preparation of Product Quality Review (PQR) report for products manufactured by TPCs.
11) Preparation of Master Product File for products manufactured by TPCs.
12) Customer Complaint Management for products manufactured by TPCs
2.Local Supplier Auditing
1) Negotiate audit schedules with the suppliers (part of new CMO Due Diligence).
2) Serve as a sub-auditor.
3) Update and manage master supplier list.
4) Audit observations CAPA tracking
3.Initiate quality agreements with TPCs, including creation of Quality Technical Agreements (QTA), and conduct periodic review on the arrangements.
1) Upload and align QTA in QUMAS system in accordance with APAC.
2) Update and manage QTA tracker
4.Preparation of the required regulatory, customer, and external audits
5.Updating and creating of SOPs and templates.
6.Prepare GMP documents.
7.Artwork Technical Review
[QUALIFICATIONS]
1. Over 3 years of experience in quality related departments within GMP industry. (무균 주사제 또는 생물학적 제제 경험자 우대)
2. Bachelor’s degree or above, majoring in biological sciences, chemical engineering, pharmaceutical engineering or related.
3. Well acquainted with the MFDS standards and European standards on Good Manufacturing Practice (EU-GMP), as well as other international GMP/GIP standards.
4. Good English communication and OA skills
[ROLES]
1.Third Party Management
1) Align direction with APAC-TPO team in managing Third Party Contractors (TPCs) associated with Korea sites based on risk-mapping score.
2) Act as the point of contact for quality-related issues and/or quality improvement plans for TPCs associated with Korea sites.
3) Monitor KPI of each TPC.
4) Batch Review for release of products manufactured by TPCs.
5) Review Change Requests received from TPCs and proceed the Change Control.
6) Review key Deviations/OOSs proposed actions including assessing risks prior to allowing CMOs to continue operations and/or releasing products to markets.
7) Maintain Imported Product Management records.
8) Support transfer of technology to TPCs and outsourced laboratories.
9) Remain abreast with cGMP and local regulatory requirements relating to products.
10) Preparation of Product Quality Review (PQR) report for products manufactured by TPCs.
11) Preparation of Master Product File for products manufactured by TPCs.
12) Customer Complaint Management for products manufactured by TPCs
2.Local Supplier Auditing
1) Negotiate audit schedules with the suppliers (part of new CMO Due Diligence).
2) Serve as a sub-auditor.
3) Update and manage master supplier list.
4) Audit observations CAPA tracking
3.Initiate quality agreements with TPCs, including creation of Quality Technical Agreements (QTA), and conduct periodic review on the arrangements.
1) Upload and align QTA in QUMAS system in accordance with APAC.
2) Update and manage QTA tracker
4.Preparation of the required regulatory, customer, and external audits
5.Updating and creating of SOPs and templates.
6.Prepare GMP documents.
7.Artwork Technical Review
[QUALIFICATIONS]
1. Over 3 years of experience in quality related departments within GMP industry. (무균 주사제 또는 생물학적 제제 경험자 우대)
2. Bachelor’s degree or above, majoring in biological sciences, chemical engineering, pharmaceutical engineering or related.
3. Well acquainted with the MFDS standards and European standards on Good Manufacturing Practice (EU-GMP), as well as other international GMP/GIP standards.
4. Good English communication and OA skills