[Janssen] Quality Associate-1414603W
Description
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.
Position Title: Business Quality Executive
Reporting: RA & Market Quality Director
계열사: 한국얀센
근무지: 서울
[Position Summary]
- This position 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).
- He/she is also responsible for compliance with the elements of the Johnson & Johnson Quality Policy that are applicable to the GMP/GDP activities the LOC undertakes. In this role he/she has defined authority and responsibility for ensuring that quality system and processes are implemented and maintained according to Market Quality Manual.
[Responsibility]
1. Quality Systems
- Implement the Quality System via transposition of the requirements of the Market Quality Manual (MQM).
- 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 per MQM 3.4.
- Prepare, update and approve LOC procedures in accordance with local GMP/GDP, MQM and J&J requirements.
- Execute minimum requirements regarding lifecycle management of GMP/GDP 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 GMP/GDP responsibilities.
- Ensure appropriate internal and external change control systems are in place and are followed.
- Manage the preparation, execution and follow up for external inspections, and report these and any other relevant field action activity into the EDGE. Monitor quality system performance versus local GMP/GDP, MQM and J&J requirements via use of pertinent business and compliance metrics and goals.
- Drive continuous improvement in the Quality System using quality system performance information, in conjunction via periodic internal audits, deviation management, CAPA management and performance reviews.
- Notify and engage LOC Quality Head and Market Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures outlined in MQM 3.5.2.
2. Quality Process
- 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 suppliers of any critical materials (drug substances, excipients, printed packaging materials) used for local manufacturing (in-house or at external manufacturers) are qualified and periodically audited against company & local GMP standards.
- Ensure all external contactors (e.g. manufacturers, repackagers, translators, test labs, distributors, etc.) are appropriately managed and approved, and that TA are approved, reviewed annually and updated as needed.
- Ensure a robust quality system is in place that describes the reception, quarantine, storage, release and distribution stages, which guarantees product quality, identity and traceability throughout the supply chain
- Implement a documented process to control and monitor (where applicable) the temperature conditions during storage and distribution for all temperature sensitive products.
- Implement a robust process to receive and evaluate all returned goods before rejecting or re-issuing the goods.
- Ensure that all Marketing Authorizations / Product Licenses, Manufacturing / ackaging and / or Import Licenses are available and kept up to date for all marketed products.
- Ensure that any mandatory governmental re-testing is properly managed by assuring that the correct methods are used, and that all specific / national obligations plus J&J requirements are fulfilled.
- Conduct regular (self-)inspections of GMP/GDP practices 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, plus QE backup in every case of absence).
- Collaborate effectively with various internal and external partners, such as the local Health Authorities, the LSO, the manufacturing plant QA, the logistic department and any other functions supporting complaint management.
- Support the LOC management team in new product introduction and all other product portfolio lifecycle management processes.
[Requirement]
- Primary degree in Chemistry / Pharmacy / Microbiology / Medicine or equivalent;
- At least 2 (ideally 5) 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;
- Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes;
- Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP;
- Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners;
- Knowledge and full understanding of the J&J Quality Policy (POL 001), and the procedures and processes outlined in this Manual;
- Full competency in local languages and a working knowledge of English
[지원방법] 온라인 또는 이메일
1. http://jobs.jnj.com/ 에서 1414603W 써칭 한 후, 해당 포지션에 Apply Now
2. 메일 문의 및 지원
recruitment-jnj@its.jnj.com
[유의 사항]
1. Ms-word 또는 PDF 형식의 이력서 & 자기소개서(또는 경력 소개서)를 한 개의 파일로 제출
2. 마감일: ASAP / 회사 사정에 따라 조기 마감 될 수 있습니다.
(서류 전형합격자에 한해 개별적으로 연락, 향후 job opening 시talent pool 로 활용 됩니다)
Qualifications
above
Primary Location:Asia Pacific-South Korea-Seoul-Yongsan-gu
Organization: Janssen Korea, Ltd. (7220)
Job Function: Compliance
Description
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.
Position Title: Business Quality Executive
Reporting: RA & Market Quality Director
계열사: 한국얀센
근무지: 서울
[Position Summary]
- This position 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).
- He/she is also responsible for compliance with the elements of the Johnson & Johnson Quality Policy that are applicable to the GMP/GDP activities the LOC undertakes. In this role he/she has defined authority and responsibility for ensuring that quality system and processes are implemented and maintained according to Market Quality Manual.
[Responsibility]
1. Quality Systems
- Implement the Quality System via transposition of the requirements of the Market Quality Manual (MQM).
- 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 per MQM 3.4.
- Prepare, update and approve LOC procedures in accordance with local GMP/GDP, MQM and J&J requirements.
- Execute minimum requirements regarding lifecycle management of GMP/GDP 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 GMP/GDP responsibilities.
- Ensure appropriate internal and external change control systems are in place and are followed.
- Manage the preparation, execution and follow up for external inspections, and report these and any other relevant field action activity into the EDGE. Monitor quality system performance versus local GMP/GDP, MQM and J&J requirements via use of pertinent business and compliance metrics and goals.
- Drive continuous improvement in the Quality System using quality system performance information, in conjunction via periodic internal audits, deviation management, CAPA management and performance reviews.
- Notify and engage LOC Quality Head and Market Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures outlined in MQM 3.5.2.
2. Quality Process
- 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 suppliers of any critical materials (drug substances, excipients, printed packaging materials) used for local manufacturing (in-house or at external manufacturers) are qualified and periodically audited against company & local GMP standards.
- Ensure all external contactors (e.g. manufacturers, repackagers, translators, test labs, distributors, etc.) are appropriately managed and approved, and that TA are approved, reviewed annually and updated as needed.
- Ensure a robust quality system is in place that describes the reception, quarantine, storage, release and distribution stages, which guarantees product quality, identity and traceability throughout the supply chain
- Implement a documented process to control and monitor (where applicable) the temperature conditions during storage and distribution for all temperature sensitive products.
- Implement a robust process to receive and evaluate all returned goods before rejecting or re-issuing the goods.
- Ensure that all Marketing Authorizations / Product Licenses, Manufacturing / ackaging and / or Import Licenses are available and kept up to date for all marketed products.
- Ensure that any mandatory governmental re-testing is properly managed by assuring that the correct methods are used, and that all specific / national obligations plus J&J requirements are fulfilled.
- Conduct regular (self-)inspections of GMP/GDP practices 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, plus QE backup in every case of absence).
- Collaborate effectively with various internal and external partners, such as the local Health Authorities, the LSO, the manufacturing plant QA, the logistic department and any other functions supporting complaint management.
- Support the LOC management team in new product introduction and all other product portfolio lifecycle management processes.
[Requirement]
- Primary degree in Chemistry / Pharmacy / Microbiology / Medicine or equivalent;
- At least 2 (ideally 5) 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;
- Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes;
- Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP;
- Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners;
- Knowledge and full understanding of the J&J Quality Policy (POL 001), and the procedures and processes outlined in this Manual;
- Full competency in local languages and a working knowledge of English
[지원방법] 온라인 또는 이메일
1. http://jobs.jnj.com/ 에서 1414603W 써칭 한 후, 해당 포지션에 Apply Now
2. 메일 문의 및 지원
recruitment-jnj@its.jnj.com
[유의 사항]
1. Ms-word 또는 PDF 형식의 이력서 & 자기소개서(또는 경력 소개서)를 한 개의 파일로 제출
2. 마감일: ASAP / 회사 사정에 따라 조기 마감 될 수 있습니다.
(서류 전형합격자에 한해 개별적으로 연락, 향후 job opening 시talent pool 로 활용 됩니다)
Qualifications
above
Primary Location:Asia Pacific-South Korea-Seoul-Yongsan-gu
Organization: Janssen Korea, Ltd. (7220)
Job Function: Compliance