Senior QA Validation Specialist
As a Senior QA Validation Specialist, you will lead and manage Site validation activities, as assigned, to ensure that validations are in compliance with company procedures & regulatory requirements and cGMP expectations.
You will be reporting directly to the Validation Manager, and be based in Tuas.
This is a permanent role.
• You will act as an SME for various validation domains such as sterile assurance & aseptic practice (i.e. autoclave, SIP, filter, isolator), cleaning, SUS, E&L, shipping and provide QA oversight.
• You are the Author and maintain the quality system SOPs for validation.
• You will define validation approach that is technically sound and are compliant
• You will author Validation Plans and Reports, including Continuous Validation Plan .
• You are responsible to review and approve validation deliverables.
• You will provide solutions to achieving validation requirements.
• You are required to collaborate with Operations to define the validation schedule and support the timely completion of activities as per schedule.
• You will drive efficiency, improvement and robustness in site validation systems
• You will be the link with Global Validation for technical information, and standards roll out.
• You will assess impact to validation and validation status during change management, and define appropriate validation requirements and approach to maintain validated status of systems.
• You will perform Annual Periodic Review and prepare the review report.
• You should have effective interfaces with internal and external stakeholders to ensure effective communication with and cascades from Global functions.
• You will be the front for validation topics during audits
• You will comply with company requirements on EHS
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: 30th November 2018
Ideally you should be an experienced candidates with the attributes below:
At least University basic degree in a Science or Engineering discipline
•At least 5 years of experience in pharmaceutical industry or related regulatory fields
•Requires candidate with experience in sterilization and cleaning validation
•Must have GMP knowledge and experience
•Experience in SAP for deviation, change control process is plus
Good communication 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.
You may apply for this position online by selecting the Apply now button.
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