Senior / QC Specialist (ELISA exp required)

Job description

Details:
Our Company
At GlaxoSmithKline (GSK) we are dedicated to improving the quality of human life by enabling people to do more, feel better, live longer. GSK is one of the world's leading research based healthcare companies, with over 100,000 employees in 150 countries across our Pharmaceuticals, Vaccines and Consumer Healthcare business.

We are proud of the difference we make and in 2016, FORTUNE Magazine ranked GSK #1 on its list of companies that are changing the world. The 'Change the World' list recognises companies that have made significant progress in sustainable, scalable approaches to addressing societal problems as part of their company strategy. Put simply, our focus is on improving access and affordability of medicines, regardless of where people live or their ability to pay.

GSK has been present in Asia for over 50 years and our commitment to the region is strengthened by the establishment of our purpose-built headquarters for Asia. Situated in Singapore, GSK Asia House is a further step in our long-standing strategy to grow and diversify our company - emphasizing the globally balanced business we have built over the years. To better support Asia, we focus on developing talent to improve our ability to make the right decisions for healthcare professionals, patients and consumers across the region.

GSK Vaccines grew by 14% in 2016 and is one of the largest in the world. Every year we distribute nearly 1 billion doses to 170 countries, of which over 80% were supplied to developing countries. We produce 30 paediatric and adult vaccines, 11 of which are world first, to prevent a range of infectious diseases including; 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.

The Role
As part of the Quality team reporting to QC Lead, the focus of your role is to provide technical support to the chemistry team.

Your key responsibilities include:
• Participates and supports GMP audits
• Manages/ support department/ site projects and initiatives
- Writes/ perform reviews of required GMP documentations such as SOP, protocols and reports
• Supports/ writes notifications (events and deviations, changes (CCs) and/or CAPAs
- Performs thorough investigation and propose effective CAPA to prevent recurrence
- Performs thorough assessment of changes and proposes the appropriate activities
- Ensures timely closure investigation, CC tasks and CAPA
• Lead and manage complex tasks such as continous improvements, department and site projects and initiaitives etc. with guidance.
• Problem Identification and Solving
- Identifies and reports problems in QC. Recommends and coordinates appropriate corrective actions as necessary.
• Manage/ Support reagents validations within the site in QC and with Belgium (Headquarters for GSK Vaccines)
- Deliver timely implementation of projects with full compliance to corporate, regulatory and external agency regulations (as applicable)
- Manage and implement changes (CCs) required by QC team; including but not limited to reagent validation
- Perform reagent validation/ bridging testing activities (where required)
- Ensure reagents are promptly validated and released for QC/ OMCL testing
- Provides guidance, supports and technical expertise on reagent related matters
- Establishes strategies for reagent validation in collaboration with testing teams, Statistican as well as with other department (QA, RA etc.)
- Analyses validation data using appropriate statistical tools with the help with statisticians
- Generate statistical report using appropriate statistical tools (where required)

What We Can Offer You
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.

Application Process
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: 4-Oct-2017

*LI-GSK

Contact information:
You may apply for this position online by selecting the Apply now button.

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jobDetails

Desired profile

Basic qualifications:
• University degree in life science, biomedical or biochemistry
• At least 1 year of laboratory experience in ELISA

Preferred qualifications:
Technical
• Competent technical skills in the followings:
- Common laboratory techniques (advantage)
- Standard, internal control and antibody qualification/ validation (advantage)
- computer system validation
• Knowledge of cGLP & cGMP
• Preferably with knowledge of statistics (advantage)
• Preferably with SAP knowledge (advantage)

Business
• Effective report writing skills
• Planning and Organizing skills
• Good interpersonal and communication skills
• Effective team player
• Leadership skills
• Analytical skills with logical thinking
• Negotiation & influencing skills