Details

Contract

Full-Time

Location

Singapore, Singapore

Department

Life Sciences

Openings

1

Job ID

47724746

Be a part of a revolutionary change. At PMI, we’ve chosen to do something incredible. We’re totally transforming our business, and building our future on smoke-free products with the power to improve the lives of a billion smokers worldwide. With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions. It’s so rare in R&D that everything aligns to create the ideal conditions for outstanding work. Right now, at PMI, that’s exactly what’s happening. R&D is the driving force for our bold new vision: to replace cigarettes with a revolutionary portfolio of alternative products. Join us and you’ll have the resources, support and technology you need to break new ground and see ideas come to life. You’ll be surrounded by some of the brightest scientists in their fields, with fast access to subject experts and commercial decision-makers. If you’re creative, courageous and ready to take risks, you can make a huge impact and propel your career in an endless number of directions. Ultimately, by delivering our smoke-free future, your work could change the lives of a billion smokers. Your ‘day to day’ • Lead computerized system validation project approach. Establish the validation strategy of computerized system and QA review all documentation produced by the project SME. Maintain and insure proper validation state of system within his scope of competency. Ensure training of project team members and users of the system regarding validation and data integrity. Ensure that projects plan and change management activities are properly scheduled and are adequately staffed. • Perform & document risk assessment of systems and propose validation recommendation. Document and register systems. • Lead computerized system validation by defining validation approach. Train, support and coach validation subject matter expert (SME). • Control validation documentation by performing quality review of SME documentation produced to support the system validation including managing deviation and CAPA. • Liaise with IT / Business stakeholder to optimize validation effort by defining workload of requested validation activities. Advice on technical solutions to reduce validation effort. Optimize systems change management, support test automation strategy and Agile approach. Who we’re looking for • Bachelor's degree in a relevant discipline. Master of Science or equivalent is preferred. • At least 5-10 years of experience in computerized system activities or validation activities. • Information Technology and regulated business experience would be an asset Experience in computerized system validation (CSV/GAMP5) • Knowledge of regulatory framework such as GCP, GLP, GCLP, FDA 21 CFR part 11 and ISO 17025. Knowledgeable in R&D, Product Life cycle and Laboratories processes, Product Testing, Biological Medical Research, Product Research, Clinical Good Practices & IT , GAMP 5, ITIL, COBIT and Quality Management Systems • Experience with cloud technologies (IaaS/PaaS/SaaS), agile methodologies, SDLC and project management, experience in writing main validation deliverables such as Validation plan and Report LIMS and Clinical systems would be an asset. What we offer Our success depends on the men and women who come to work every single day with a sense of purpose and an appetite for progress. Join PMI and you too can: • Seize the freedom to define your future and ours. We’ll empower you to take risks, experiment and explore. • Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong. • Pursue your ambitions and develop your skills with a global business – our staggering size and scale provides endless opportunities to progress. • Take pride in delivering our promise to society: to improve the lives of a billion smokers. If you believe you would be a good fit to the requirements of the role, please submit your application online. Only candidates who fit the hiring requirements will be contacted. The successful candidate will be hired on the local employment terms and conditions in Singapore. #LIjobs

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