Senior Quality Validation Specialist
Purpose of the role:
You are responsible to ensure that the manufacturing facilities, processes, analytical methods and systems are validated in full compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements in order to meet the stipulated product quality standards in line with the established specifications of the
• You will participate / lead in the conduct of audits on equipment / system, and internal cross-functional departments involved in the manufacture of bulk drug substances to ensure full GMP and regulatory compliance.
• You will draft, compile, review and update appropriate policies and procedures in support of the validation activities on site.
• You are responsible to assess, review and approve changes that may have an impact on the validation status of the facility, processes or systems on site
• You are responsible to review and authorize validation protocol documents and reports
• You are to ensure consistency with agreed criteria and quality system.
• You will participate as an audit team member and/or as a subject matter expert in the preparation of site audits by internal corporate groups and external
• You will participate in the conduct of investigations relating to customer complaints, returned / recalled goods, investigations of failure, etc to assess root causes of the complaints, and evaluate the impact of corrective actions on the validation status.
• You will act as a Validation Coordinator in projects that are deemed to have •Adherence to validation and project plan schedule for validation.
• You will perform the QA role in New Product Introduction (NPI) projects to ensure that the manufacture complies with GMP requirements.
• You will lead the cleaning validation program to ensure that all cleaning methods used are validated in compliance with regulatory requirements.
• You need to ensure that validation review of systems or processes are conducted on a periodic basis to ensure that the validation status is maintained, and make recommendations for re-validation as required, pending outcome of the validation review
• You will take on Validation Coordinator role for Method Validation to assess, review and approve changes that may have an impact on the method validation status on site.
Other activities as assigned.
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: March 30 , 2019
Ideally, you should be someone with these criteria:
• At least an honors degree in the relevant science / engineering discipline
• At least 5 years of relevant experience in the pharmaceutical industry
• Extensive knowledge of GMP and validation
• Extensive knowledge of quality and manufacturing processes
• Good knowledge of corporate management systems
• Good audit skills
• Detailed knowledge of regulatory processes
• Good interpersonal skills
• Good oral and written communication skills
• Good investigating 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 recognizes companies that have made significant progress in sustainable, scalable approaches to addressing societal problems as part of their company strategy.
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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