Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
1. 포지션: Sr. Commercial Quality Specialist
2. 계열사: 존슨앤드존슨 컨슈머 (Consumer Health)
3. 근무지: 서울시 용산구4. 근무 형태: Regular [Summary]- Responsible for the quality of and meeting the applicable requirements for the products that the LOC markets.- Responsible for compliance with the elements of the Johnson and Johnson Quality Policy that are applicable to the GxP activities the LOC undertakes. In this role, he/she has defined authority and responsibility for ensuring that quality system and processes implemented and maintained according to Commercial Quality Manual [Responsibilities]Quality Systems- Ensure appropriate change control procedures are followed. Monitor change control status for timely closure and support issues related to TrackWise ETS.- Ensure appropriate quality event management procedures are followed. Monitor QEM status for timely closure and support issues related to TrackWise ETS.- Prepare quality metric data for QSMR and monthly review for change control and purchasing control. Keep related trackers up to date.- Update and keep product list up to date on TruVault.- Establish and revise LOC procedures in accordance with local GxP, CQM and J&J requirements for change control.- Support internal audit and HA inspection for auditing and documentation • Support supplier qualification and document management. Quality Processes- Manage the management of QA activities for imported products release from End to End, incoming inspection, sample shipment arrangement, release checklist preparation and so on.- Ensure the redressing requirement from End to End, visual check against retention sample with approved artwork, confirming redressing artwork and preparing redressing instruction and so on. - Oversee the new product introduction process including test method transfer, QC tests, change control management and master formula preparation.- Establish Annual Product Quality Review in a timely manner.- Ensure warehouse 3PL oversight and self inspection by periodic walk-through.- Conduct supplier and distributor management. [Requirements]- Primary degree in Chemistry / Pharmacy / Microbiology or equivalent.- At least 5 years’ experience in the Pharmaceutical or related industry, ideally with a mix of Manufacturing / QA operations.- Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes.- Up-to-date knowledge of relevant pharmaceutical legislation and GxP including but not limited to GMP/GDP.- Korea and English bilingual is preferable. At least, fluent English in both verbal and written. Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of a new entity within New Consumer Health and your employment would be governed by New Consumer Health’s employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by New Consumer Health at an appropriate time and subject to any necessary consultation processes. [지원 방법]
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