Your Responsibilities :
GlaxoSmithKline (GSK) is a science-led global healthcare company with a special purpose : to help people do more, feel better, live longer.
We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies.
We are proud of the difference we make.
GSK has ranked 1st in the Access to Medicines Index all five times since its launch in 2008 and FORTUNE Magazine ranked us #1 on its Change the World list’ which recognises companies that have made significant progress in sustainable, scalable approaches to addressing societal problems as part of their company strategy.
hepatitis, rotavirus and HPV infections, diphtheria, tetanus, whooping cough, measles, mumps, rubella, bacterial meningitis and influenza.
Our Tuas site, one of only two GSK global vaccines manufacturing facilities worldwide, operates around-the-clock to manufacture the active ingredient used to make a GSK vaccine that protects children against pneumonia.
Job purpose :
As the QC lead for chemistry ASAT processes, you are responsible to oversee the QC processes and oversight, perform development, validation / verification activities where required.
a)Manages team to assure adherence to team / department / site KPIs
b)Participates and supports GMP audits
c)Leads and manages department / site projects and initiatives with minimum guidance
d)Keeps up-to-date on the regulations / development concerning biopharmaceutical QC activities (relevant to area of responsibiliy) to ensure quality control operations are in compliance to applicable corporate, regulatory and external agency regulations and guidelines
e)Supports the manager to ensure knowledge retention and effective training within team
f)Ensures all in-use procedures are current and compliant
g)Writes / reviews / approves required GMP documentations such as SOP, protocols, reports
h)Writes / reviews / approves notifications (events and deviations) and / or CAPAs
i)Writes / reviews / approves changes (CCs)
j)Leads / manages investigation of non-conformities (events and deviations)
k)Provides guidance, support and technical expertise on quality control operations (relevant to area of responsibility) to ensure full compliance to applicable corporate, regulatory and external agency regulations
l)Manages local compendium system
m)Problem Identification and Solving :
This includes managing non-conformities (lab and facility etc.), local CAPAs and leading investigations as necessary.
Specific to job role
a)Provides technical expertise and consultation to testing teams on technical matters.
b)Lead / manage projects
Key Responsibilities area : 1.GMP Compliance
2.Quality metric performances
3.Continuous improvement projects / initatives
4.Leadership and interpersonal skills
5.Finanical metric performances
Basic qualifications :
You are a passionate quality professional with the following attributes :
Preferred qualifications :
Why GSK? :
GSK’s dedication to the wellbeing of our employees is reflected in the benefits we offer; including healthcare for yourself and dependents, performance related bonus, long term incentives and a host of other flexible offerings you can tailor to your own preferences.
We also offer a range of employee health and wellbeing programs including our truly unique Partnership for Prevention program, a global commitment by GSK to provide all employees with up to 40 preventative healthcare services bringing to life our mission to : do more, feel better and live longer.
At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
If you would like to join us in innovating and inspiring changes in the industry, we urge you to apply.
Closing date for applications : 30th April 2018