Posted Date: May 12 2023
Are you energized by a Quality Assurance role that allows you to accelerate compliance in a highly technical and regulated environment? If so, this Operational QA Staff role could be an exciting opportunity to explore.
As an Operational QA Staff, you will manage/lead/be responsible for working on the shop floor addressing quality issues during production shift operating hours. Additional responsibilities include supporting incident and deviation investigations, participation in internal auditing activities and batch record review.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Vaccine Product Release for pharmaceuticals
- Approve release of pharmaceutical products, which include but 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, local repacker in ensuring GSK and regulatory requirements are met
Deviation and Incident Management
- Lead and support timely completion of deviation investigation and ensure root cause and CAPAs are identified.
- Support LOC Quality Lead
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 Licensee
- 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
- Preparation about reference standard for Vaccine
- Payment about local release testing fee on a monthly basis
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.
Local release testing support
Why you?
Basic Qualifications:
Bachelor’s degree in pharmacy or bio-science related
At least 3 years’ experience in QA pharmaceutical industry
Experience in the management/use of quality system
- LI-GSK
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. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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.
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