You will be planning, leading, supervising and providing Quality oversight to operational activities of Quality Control (QC), Incoming Materials Management (MM) and Sterility Assurance (SA).
In this role, the key responsibilities are as follows:
- Responsible for the site Environmental and Clean Utilities Monitoring Program and ensure appropriate and compliant handling of out of alert/action results. Responsible for Environmental and Clean Utilities trend review and lead improvement efforts
- Manage training program for Good Aseptic Practice, Health and Hygiene, Good Cleanroom Behavior and Environmental Monitoring
- Provide QA oversight to SA areas such as Aseptic process simulation, Aseptic Operators' qualification program, Aseptic Processing, Isolator technology, Cleaning and Disinfectant program, Sterilization, Single-use systems, SA risk management and investigation
- Support investigations of contamination or breach of sterility
- Lead SA improvement efforts
Management and Planning
- Plan and organize the team's day to day activities
- Leads a team to perform operations
Training and Development
- Plan and develop working knowledge and stakeholder management of the team of QA Executives
What We Can Offer You
GSK's dedication to the well-being 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 well-being 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.
You are a passionate Quality professional with the following attributes:
• At least University basic degree in a Science or Engineering discipline.
• 7 - 10 years experience in the pharmaceutical industry in GMP regulated areas.
• In-depth understanding of cGMP regulatory and legal requirements as applied to quality assurance of pharmaceutical manufacturing.
• Extensive knowledge and hands-on experiences of pharmaceutical manufacturing processes
• Good understanding of vaccine production technology, or various fields of biotechnology such bio-pharmaceutical manufacturing, QA (microbiology) and sterility assurance.
• Good understanding of cGMP requirements as applied to quality assurance of vaccines and aseptic medicinal product manufacturing
• Ability to apply optimal quality assurance standards to promote a business edge.
• Ability to facilitate business activities compatible to international regulatory environment.
• Ability to communicate effectively within the site organization and across the network.
• Good people management and risk management skills
• Working knowledge of FDA/EU/ICH/WHO as well as all other relevant regulatory and technical guidelines.
• Possess Analytical and Quality performance mindset.
• Demonstrate professional & ethical integrity.
• Fluency in the English language.
• Demonstrated leadership qualities and supervisory skills
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.
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 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.
You may apply for this position online by selecting the Apply now button.
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