제약사업부 QA Specialist (안산)

ABOUT ABBOTT :Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.Established PharmaceuticalsWe are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.Primary Job Function :This position is responsible for quality control, document control, supplier management, artwork development and revision, activities related to product release, QC reagents and standard supply, complaint handling and general management activities complying with Korea GMP/GIP, applicable regulatory standards and Abbott corporate requirements.(Office location : Abbott warehouse in Ansan)Core Job Responsibilities : Product batch release Inspect packaging materials and document on an inspection record Issue redressing instruction Review packaging records for products locally redressed and verify that the redressing was appropriately conducted Review incoming inspection records for finished goods including retrieving shipping temperature data First review of Batch records on QC testing, redressing, label inspection Issue Certificate of Product related Request QC testing to contracted labs Request and maintain retention samples Issue PQR Complaint Management Intake complaints from internal / external customers and create complaint records in Track Wise(TW) Communication with stakeholders and coordination for product compensation Send back corresponding samples to manufacturing sites for investigation and close TW records based on global investigation Inform investigation results to customers if requested Change Control, Nonconformance(NC) and CAPA Management Issue or review records for change and NC locally initiated Conduct Impact assessment, investigation, set up action plans, effectiveness check as per related procedures Maintain related records and track progress status Manage CC/NC/CAPA list and completion Artwork Management Develop Artwork for finished products licensed in Korea Issue Label Change Request (LCR) via Agile and track artwork change Coordinate schedule of implementation with local SCM and global artwork coordinator (PLM) Internal and external audit/ inspection Address inspector’s requests during audit and coordinate other dept’s readiness Set up action plan for any observations identified by auditors after root cause investigation, and complete required actions and effectiveness check Maintain any other related documents Supplier Management Participate supplier audit as an auditor or subject matter expert (SME) according to a plan approved in advance. Track action plan from auditees. Coordinate/Conduct supplier evaluation and performance monitoring Issue/Maintain Approved Supplier List (ASL) Make a Quality agreement with suppliers under EPD responsibility Maintain any other related documents. Scope of supplier management is negotiable and can be reassigned within the team if necessary. Laboratory management Participate selection process of proper local lab for TMT Coordinate TMT between transferring lab and receiving lab Review TMT protocol and report Cooperation with MS&T to issue TMT protocol and report Order reagents and standard materials required for local QC testing. Communication with ARS and CSCC team to obtain required documents for import Manage importing process of the reagents etc. including government approval Make a service contract and QTA with local 3rd Party Lab Document Management Establish and revise local procedures and product master file Review suggested draft for revision of local procedures Archive the release approval and other import records Manage all QA records and documents Conduct impact assessment of local procedures when global or regional procedures are revised Darius Coordinator (negotiable) Training Maintain training matrix & prepare training plan Training coordinator Others Review records of returned product reports. Manage RINR regulation review tracker. Address/Support any regulatory submission to local health agency Attend training for drug or food & Complete training documentation Support Validation including mapping study through management of outsourced service providers. Manage financial activities for QA team such as initiation of Purchase order and requesting QC testing expense Back up QA manager(except release approval) and QA Specialist during his(her) absenceMinimum Education/Experience/Knowledge required : Bachelor’s degree or equivalent in pharmacy, chemistry, biology or related scientific discipline Pharmaceutical qualifications in an experienced quality system management discipline or equivalent would be desirable. More than 3 years’ experience working and managing a quality assurance or quality control in pharmaceutical company. Familiarity with the Pharmaceutical Law and related regulations and GMP/GIP knowledge Proficiency in MS Office Basic English Communication Skills