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1. 포지션: Quality Project Lead
2. 계열사: 한국얀센 (Janssen)
3. 근무 형태: Permanent
1) The Quality Project Lead is responsible for the quality of, and meeting the applicable requirements for, the products that the LOC markets, or the products that it produces for other companies (including all named-patient materials, product samples and/or clinical supplies).
2) He/she is also responsible for compliance with the elements of the Johnson & Johnson Quality Policy that are applicable to the GxP activities the LOC undertakes including but not limited to GMP/GDP activities, unless agreed to be otherwise managed by other Q&C functions such as GCDO, MAF, CLS, CS and Make Q&C. In this role he/she has defined authority and responsibility for ensuring that quality system and processes are implemented and maintained according to Business Quality Manual.
1) Quality Systems
- Implement the Quality System via transposition of the requirements of the Business Quality Manual.
- Maintain an up to date list of all relevant product sourcing, supply routes (including exports), product licences (marketing authorizations), relevant authorizations (e.g. manufacturing, packaging, importation, warehousing, distribution, testing, narcotics handling, etc.), and TA.
- Prepare, update and approve LOC procedures in accordance with local GxP regulations, BQ Manual and J&J requirements.
- Execute minimum requirements regarding lifecycle management of GxP related documents and records (creation, approval, distribution, revision, retrieval, retention, disposition) to ensure regulatory compliance and business continuity.
- Ensure the provision of appropriate training for all job functions with GxP responsibilities.
- Monitor quality system performance versus local GxP regulations, BQ Manual and J&J requirements via use of pertinent business and compliance metrics and goals.
- Notify and engage LOC Quality Head and Business Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures.
2) Quality Processes
- Ensure that robust processes are installed and maintained to ensure accuracy of printed packaging (labelling) text, including correct translation from source documents into local product text versions and appropriate review at critical stages, and that all people involved in text management have been trained accordingly.
- Ensure that all Marketing Authorizations / Product Licenses, Manufacturing / Packaging and / or Import Licenses are available and kept up to date for all marketed products.
- Conduct regular (self-)inspections of GxP practices with focus on GMP/GDP activities, that are applicable on the supply chain within the responsibilities of the Local Operating Company.
- Provide an effective procedure and adequate resources to handle product and AE complaints, escalate critical product issues and conduct recalls and other field actions in a timely manner (including outside business hours.
- Collaborate effectively with various internal and external partners, such as the local Health Authorities, the LSO, the manufacturing plant Q&C, CLS Q&C, Controlled Substance Compliance Manager, the logistic department, JJRC, and any other functions supporting complaint management.
- Support the LOC management team in new product introduction and all other product portfolio lifecycle management processes.
1) Primary degree in Chemistry / Pharmacy / Microbiology / Medicine or equivalent;
2) At least 5 (ideally 10) years’ experience in the Pharmaceutical or related industry, ideally with a mix of Manufacturing / QA operations, Distribution Warehouse management, Regulatory Affairs and some Sales & Marketing experiences. Where the position requires oversight of manufacturing / packaging / testing operations activities (internal or external), Manufacturing / QA operations experience is essential;
3) Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes;
4) Up-to-date knowledge of relevant pharmaceutical legislation and GxP including but not limited to GMP/GDP;
5) Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners;
6) Full competency in local languages and a working knowledge of English
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Janssen Korea, Ltd. (7220)