Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
Not Mentioned
Description
- Release 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
Local release testing support
- 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.
Qualifications
Highest qualification: University
- At least 2 years’ experience in QA pharmaceutical industry or licensed pharmacist of Korea
- Experience in the management/use of quality system
- Self-starter with continuous improvement mindset
- Strong in implementation with business mindset
- Enjoy challenge and problem solving.
- Strong Team player, able to interact and communicate well
- English proficiency (written and spoken)
- Operational experience, knowledge and application of cGMP/GDP