Senior QA Executive, Vaccines
• Bachelors in Engineering/Science
• Well versed in GMP standards
• Basic understanding of regulatory inspection requirements
• Strong communication skills
• Broad experience in the pharma industry
In addition, you have the business acumen to apply optimal quality assurance standards across your area of responsibility.
• Risk Management skills
GSK Vaccines has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in 160 countries, preventing a range of diseases such as; 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.
As a Senior QA Executive, you will have oversight over manufacturing and batch usage decision activities to maintain continuous GMP (cGMP) compliance in line with GSK and regulatory standards.
Key Responsibilities include:
1. QA Oversight
- Interact with manufacturing personnel in day-to-day operations to ensure cGMP compliance.
-Support compliance in production areas by routinely conducting QA checks such as checklist review, housekeeping checks, review of line clearance checks, verify compliance with SOPs etc.
-Authorize campaign changeovers and participate in facility walkdowns where required
-Provide QA input and assistance in managing unplanned event investigations, CAPA implementation and change control monitoring.
-Ensure changes implemented on production areas are properly management to prevent potential adverse impact to operations.
-Authorize QA processes eg Production Process Orders, Quality Tagouts, Conditional equipment releases, room release etc.
2. Review and approval of the following documentation as assigned:
-Master Batch Records
-Quality tag outs
In this role, you will ensure that Quality issues related to manufacturing functions are resolved in a timely and compliant manner to meet GMP requirements and regulatory expectations. In addition you will provide robust and practical recommendations in operational issue management.
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: 23 February 2018
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 demonstrated by 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.
You may apply for this position online by selecting the Apply now button.
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