Senior / QA Associate (Sterility Assurance)
- NITEC or Diploma in Microbiology, Biology, Biotechnology, Life Science or relevant Science discipline
- Good sampling and analytical skills
- Prior experience in working in clean classified environment will be an advantage
- Knowledge of clean room process & cGMP will be an advantage
- Organized individual
- Team player
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.
Based in the Quality department and reporting to QA Lead (Sterility Assurance), you will be part of a team supporting the environmental monitoring activities on-site to be in compliance with GMP standards.
Key responsibilities include:
- Environmental monitoring (EM)
- Perform routine environmental sampling in controlled environmental areas
- Encode non-viable particle (NVP) results into SAP and review NVP results
- Assist in EM data trend analysis
- Conduct EM OJT training
- Ensure EM equipment are calibrated before due date by coordinating with calibration and maintenance coordinator
- SOP (EM related) author and owner
- EM OJT material author and owner
- Deviation management
- Event (EM related) initiator and reviewer
- Identify and report problems encountered to QA Lead, including participation in problem solving and implementation of corrective actions
- Audit Readiness and Validation
- Support/perform L1 audit on EM
- Participate in method and/or equipment verification/validation
- Comply with cGMP and EHSS requirements at all times
- Practice 6S and ensure good housekeeping of work area and equipment, including cleaning where appropriate
This role is on normal office hours, Monday to Friday. You may need to support weekend (OT) or afternoon shift (from 2pm onwards) at times.
New joiner will use the title of "Associate" instead of "Analyst" due to internal naming.
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.
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: 20-Aug-2017
You may apply for this position online by selecting the Apply now button.
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