Quality Specialist_Product Release (1Y contract)

Site Name: Korea - Seoul Posted Date: Jul 14 2022 At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realize that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process. We will be delighted to hear from talented individuals that align with our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity with Courage, Accountability, Development, and Teamwork. When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance, and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us. As a , we empower you to be yourself, share ideas and work collaboratively. This position is to ensure that pharmaceutical products released into Korea market is timely and compliant with GSK and MFDS regulatory requirements. The position holder is responsible to: Authorize pharmaceutical products are fit for purpose and suitable for distribution in Korea. Ensure GSK and local regulatory compliance requirements for the pharmaceutical products are met. Contribute to the continuous improvement of the Quality Management System. Key Responsibilities Product Release for pharmaceuticals Approve release of pharmaceutical products, which include but are not limited to review of receipt documentation, temperature records, in-market test result and repacking. Responsible to work with 3rd party logistics service providers, such as warehouse, and local repacker in ensuring GSK and regulatory requirements are met. Deviation and Incident Management Timely complete deviation investigation and ensure root cause and CAPAs are identified. Corrective and Preventative Actions (CAPA) Ensure all operational-related work’s CAPAs are identified, implemented, monitored, and closed out on time. Change Management Lead and support change control process Liaise and coordinate change control process with LOC stakeholders in ensuring the quality requirements are addressed. Quality Agreement / Technical Terms of Supply with Manufacturing Sites and License Act as LOC point of contact for Quality Agreement / TTS for the identified products. Coordinate the review and approve Quality Agreement / Technical Terms of Supply with manufacturing supply sites. Repacking Ensure repacking procedures are complied with LSOP, PGSOP and LOC regulation Review and Approve for repacking batch record about repacked vaccine products before repacking operation KPS(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 Vaccines and Biological products Audit / Regulatory Inspection Support GMP audit and regulatory inspection within LOCQ and GSK warehouse or distribution sites managed by LOC QMS Subject matter expert for assigned QMS topics Perform management monitoring or internal business topics for assigned QMS topics SOP owners for assigned QMS topics. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: 5+ years of QC and QA experience in the pharmaceutical industry Preferably a Pharmacist Experience in the management/use of the quality system Operational experience, knowledge, and application of cGMP/GDP and local regulation in artwork, secondary repacking, warehousing, and distribution Self-starter with a continuous improvement mindset Strong in implementation with a business mindset Enjoy challenge and problem-solving Strong Team player, able to interact and communicate well English proficiency both in written and spoken *LI-GSK Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. *This is a job description to aide in the job posting, but does not include all job evaluation details. Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. Important notice to Employment businesses/ Agencies GSK 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.