Quality Specialist (Fixed term, 1.5 year)
Emploi Corée
Titre du poste : Quality Specialist (Fixed term, 1.5 year)
Entreprise : GlaxoSmithKline
Description du poste : Job PurposeThis position is to ensure that medicinal products release into Korea market are timely and compliant with GSK and MFDS regulatory requirement.The position holder is responsible to:Authorize medicinal products are fit for purpose and suitable for distribution in Korea.Ensure GSK and local regulation compliance requirements for the medicinal products are met.Contribute to the continuous improvement of Quality Management System.Key ResponsibilitiesProduct Release for medicinalsCollection/Review of batch release documents for Medicinal products, which include but not limited to review of incoming inspection result, temperature records, in-market test result and redressing records, preparation of batch release documents, etc.Preparare and Review of Vaccine Summary Protocol in compliance with internal/external guidelineResponsible to work with 3rd party logistics service providers, such as warehouse, local repacker in ensuring GSK and regulatory requirements are met.Deviation and Incident ManagementLead and support timely completion of deviation investigation and ensure root cause and CAPAs are identified.Corrective and Preventative Actions (CAPA)Ensure all operational related CAPAs are established, implemented, monitored and closed out on time.Change ManagementLead and support change control processLiaise and coordinate change control process with LOC stakeholders in ensuring the quality requirements are addressed.Quality Agreement with Manufacturing Sites and LicenseeAct as LOC point of contact for Quality Agreement for the responsible products.Coordinate the review and approve Quality Agreement with manufacturing supply sites.RedressingEnsure redressing procedures are complied with LSOP, PGSOP and LOC regulationReview and Approve for redressing batch recordKPS(Korean Product Standard) and APR(Annual Product Review)Ensure that the process for KPS and APR are in place and in use.Prepare and document KPS and APR for medicinal productsLocal release testing supportPreparation about reference standard for medicinal productsManagement payment about local release testing fee on a monthly basisAudit / Regulatory InspectionSupport GMP audit and regulatory inspection within LOC Quality and GSK warehouse or distribution sites managed by LOCQMSSubject matter expert for assigned QMS topicsPerform management monitoring or internal business topics for assigned QMS topicsSOP owners for assigned QMS topics.Customer ComplaintHandling of coustomer complaints received for the responsible products in a timely mannerRequirementsBachelor’s degree in pharmacy(Preferred) or bio-science relatedAt least 2 years’ experience in QA/QC medicinal industryExperience in the management/use of quality systemOperational experience, knowledge and application of cGMP/GDPSelf-starter with continuous improvement mindsetStrong in implementation with business mindsetEnjoy challenge and problem solvingStrong Team player, able to interact and communicate wellKorean/English proficiency (written and spoken)*LI-GSKWhy GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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Localisation : 서울시
Date du poste : Tue, 13 May 2025 23:04:06 GMT
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