JANSSEN] EXTERNAL QUALITY MANAGER

At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in pharmaceutical, medical devices and diagnostics markets, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
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1.
포지션.
External Quality Manager 2.
계열사.
얀센 (Janssen) 3.
근무지.
서울 용산구/ 송도(CMO site) 4.
근무 형태.
Regular [Primary responsibility] To oversee the quality and compliance activities of Johnson and Johnson Innovative Medicine (Here in after ‘JJIM’) for corporate & external manufacturing sites.
To ensure that the product quality and safety requirements are met in compliance to local regulatory, JJIM corporate guidelines and cGMP and thereby complying the responsibility towards patients, customers, regulators, society, and colleagues.
Ensure Quality and Compliance of JJIM products produced by External Manufacturer.
To work with cross functional team to complete External Manufacturer selection process and support timely execution of relevant technology transfer process.
To provide timely, efficient, and cost-conscious resolution of issues during the technical transfer project 1.
GxP Compliance at External Manufacturing Location/site To ensure that all manufacturing operations carried out at external manufacturing sites are complying to current Good Manufacturing Practices.
To ensure that the testing carried out at the External Manufacturing Location laboratories are complying to Good Laboratory Practices.
To ensure that quality systems are established and followed in compliance to JJIM quality systems policies at the Corporate and External Manufacturing Site.
Participate and follow up audit and assessment to achieve objectives listed above.
2.
Documentation Management To ensure that all critical/GMP documents are created, revised, identified, approved, issued, distributed, retrieved, and disposed as per Good Documentation Practices complying to JJIM corporate policies and local Regulatory requirements.
Reviewing and approving the critical documents from Ems like batch records, validation related documents, JJIM product related procedure and JJIM product related specification etc., 3.
Change Management To ensure that all Changes at External manufacturing sites related to JJIM products and Critical systems are managed through Change Control system and assessed for its impact, scientifically executed, and closed in compliance the Regulatory and Corporate requirements.
To ensure that a proper Change Control System is in place at JJIM corporate to handle all changes which have regulatory or validation Impact.
To ensure that the change control procedure is updated as per JJIM corporate procedure, and all concerned are trained on the procedure.
4.
Deviation / Non-Conformance Management To ensure that all deviations and Non-Conformances at External manufacturing sites related to JJIM products and Critical systems are suitably, scientifically, and logically handled, documented, investigated for root cause, assessed for its impact on Product Quality and Safety.
To ensure that appropriate Corrective actions are taken to mitigate the effect of deviation or non- conformance on the Product and Preventive actions are taken to mitigate the recurrence in future.
5.
Quality Audits / Quality Reviews To carry routine quality rounds at the EM site, documentation reviews to ensure compliance.
To report the audit finding to the JJIM and Contractor’s Top Management and recommend appropriate Corrective and Preventive actions to close the findings.
Review of QC documents like product analysis reports, microbial results, batch manufacturing and packaging records and releasing product to dispatch.
Attend on-line problems of raw and packaging materials and ensuring quality supply from suppliers.
Co-ordination of validation activity at location to fulfil regulatory and J&J guidelines and requirements 6.
CAPA Management To ensure that a CAPA plan is designed, agreed, and approved to comply the findings noticed during any Regulatory audit.
To ensure that the CAPA is implemented timely, tracked for its completion, monitor its effectiveness, modify if required and close it.
7.
Product Release, Distribution, Storage To ensure that the J&J products are manufactured and released timely as per GMP to the markets to ensure continuous supply of the product.
To ensure that the Products are released after complete documentation review and dispatched.
To ensure that products are suitably stored as per the specification.
Delegate the batch review to EM as per SOP and Quality agreement on Batch review delegation.
In absence of delegation, review of full batch documents.
At minimum certificate of analysis, certificate of compliance, deviations / incident investigations (if any) shall be reviewed before batch release.
8.
Complaint handling.
To design CAPA in association with the EM to mitigate the complaints from Fill and Finish sites Review of the trends to take appropriate CAPA.
9.
Critical product issue escalation/resolution & Crisis management.
To ensure that all critical product issued are immediately escalated as per corporate procedure, investigated, and resolved to ensure business continuity.
10.
Training and Development.
To train all the concerned stakeholders like EM, QC, QA and production and other allied persons on the critical quality procedures.
11.
Technology Transfers/ Validations.
To support the technology transfer, validation and launch for new products at External Manufacturers as per J&J Guidelines.
To Review related study protocol and report for the PPQ (or Process Validation), Cleaning validation and holding time study, as per the J&J Guideline.
12.
Annual Product Quality Reviews and Continued Process Verification.
To review and approve Trend data and APQR.
Correlation of APR trends with the product validation status.
To review and approve Trend data and CPV.
Correlation of CPV trends with the product validation status.
To report the Quality metrics monthly- related with EM site as an input to EQ Regional Metrics.
13.
Support to Technical group / Regulatory activity / Supply chain.
To support activity, related with new product or any vendor driven change at the site.
Vendor development raw material analysis and related trials at site to take decision for commercial supply and vendor approval.
[Qualification] Bachelor’s degree or master’s in pharmacy, Biological engineering or equivalent education.
Availability to local travel a minimum of 50% is required.(CMO Site in Songdo) Provide support to manufacturing / technical / analysis (Lab) organizations regarding aspects of GMP compliance associated with technology transfer and commercial product supply.
Remain current with international Health Authority regulations, guidelines, and quality practices associated with the pharmaceutical industry is required.
Computer literate well versed in Microsoft Office tools with the ability to communicate effectively electronically.
Fluent in English& Korean.
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