LOC Quality Executive – QC pharmaceutical
Bangkok, ประเทศไทย Design / Civil engineering / Industrial engineering
Job description
Your Responsibilities :
JOB PURPOSE
- Contract laboratory oversight
- Local testing process management including sampling, test request, test review and release
- Pharmacopoeia release testing coordination with contract laboratory
- Troubleshooting for the testing
- Training coordination
ACCOUNTABILITY:
1. Contract laboratory management
- Quality agreement preparation
- Contract KPI review and monitoring
- Communication channel between contract lab., manufacturing site and GSK Thailand
- Follow-up the testing set-up progress including qualification of equipment
- Pharmacopoeia method verification supports (Documentation/ Review and Assessment /
Coordination)
- Regular meeting with contract lab if requested
- Regular routine review for all test method
- Support Negotiation testing fee between procurement and contract lab
2. Test coordination and test release (local pharmacopoeia testing)
- Local testing process protocol set up (sampling, test request, test review and release)
- Local testing planning in accordance with tender application schedule
- Batch release: Test results review and reporting for CoA of contract laboratory for issued product
- Testing management with contract laboratory and supply site
- Support technical issue (change control, deviation, OOS, investigation etc.)
- Reference substance management
- Handling of complaints related testing
3. Others
- L1 governance
- Training coordination
- L2/L3/L4 audit support
- Issue and revise SOP
- QMS document review and in place/ in use to related SOPs
Very good in Communication in English, Writing and Reading in English
*LI-GSK
Why You?
Basic qualifications:
SPECIALISED KNOWLEDGE:
- Bachelor's degree in Pharmaceutical Science
- Minimum experience of 3 -5 years on QC in Pharmaceutical set up
- Experience in QA in Pharmaceutical industry will be advantageous.
- Knowledge in chemistry background
- Knowledge in Quality, Regulation requirement for Pharmaceutical industry and pharmacopoeia
- Good writing, speaking and reading in English
- Communication skill with all levels
- MS Office skill (Word, PPT, Excel)
Preferred qualifications:
Minimum experience of 3 -5 years on QC in Pharmaceutical set up
Why GSK? :
A science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.
We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our 3 global businesses, scientific and technical know-how and talented people
Contact information:
You may apply for this position online by selecting the Apply now button.
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.
jobDetails