Senior/QA Validation Specialist
Site Name: Singapore - Tuas
Posted Date: Feb 3 2020
We are currently looking for experienced individuals to join the vast and expandingQA teamas Senior QA Validation Executive/Specialist.
Based at our Vaccine plant in Tuas,the incumbentwill be responsible to lead and manage Site validation activities, as assigned and to ensure that validations are in compliance with company procedures & regulatory requirements and cGMP expectations. Incumbent will also be required to provide QA compliance oversight over IT and Technical Services; as assigned.
Other key responsibilities would include:
- Author and maintain the quality system SOPs for validation Define validation approach that is technically sound and are compliant
- Author Validation Plans and Reports, including Continuous Validation Plan .
- Review and approve validation deliverable.
- Provide solutions to achieving validation requirements.
- Collaborate with Operations to define the validation schedule and support the timely completion of activities as per schedule.
- Drive efficiency, improvement and robustness in site validation systems
- Be the link with Global Validation for technical information, and standards roll out.
- Assess impact to validation and validation status during change management, and define appropriate validation requirements and approach to maintain validated status of systems.
- Perform Annual Periodic Review and prepare the review report.
Ideally, we are looking for candidates with these criteria's:
- At least University basic degree in a Science or Engineering discipline
- At lease 2 years experience in pharmaceutical industry or related regulatory fields (at least 5 years for Snr QA Validation Specialist role)
- A good understanding of cGMP regulatory and legal requirements as applied to quality assurance and validation of pharmaceutical manufacturing
- Good understanding of regulatory inspection requirement
- A good working knowledge of validation, preferably with hands-on experience
- Computer skills in MS Office and familiar with web-based e-learning resources
- Potential or developing project management skills
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 welling 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.
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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