Details

Contract

Full-Time

Location

Crespellano, Italy

Department

Life Sciences

Openings

1

Job ID

37497257

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. We’re also exploring new categories, looking beyond nicotine to develop a new portfolio of innovative products. 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 and beyond nicotine future, your work could change the lives of millions. Your ‘day to day’ As Data Integrity Sr. Engineer Quality, you will lead data integrity maturity assessment and data governance by performing quality maturity assessment and QA review of all documentation produce by the SME related to data documentation. Moreover, you will maintain and guarantee proper data governance state of critical quality master data and advice on mitigation action to correct data integrity weakness. More specifically, you will: • Perform and document process and data to establish data maturity assessment. It includes the establishment of remediation recommendation and the follow-up of these activities. • Lead data governance activities by defining data owner and usage, collaborate with corporate data governance to ensure alignment, ensuring consistency of data definition and liaise with validation lead & SME to ensure proper data usage. • Control data integrity documentation and manage deviation and CAPA. • Liaise with IT and Business stakeholder to improve data integrity. It includes to guide business to replace paper data collection by validated systems, advice on technical solution to increase data integrity and reduce controls, support system changes management related to DI issues. • Lead data standard definition for storage, archives, and exchange with authorities and Liaise with external partners to improve DI practices. • Handle the coordinator role for NC/CAPA/DP and change for CSV & DI processes. • Provide training for CSV & DI related processes. Who we're looking for: • University degree in science, engineering or equivalent. • Seasoned experience in computerized system and validation activities (CSV/GAMP5). IT and regulated business experience would be an asset. • Substantial experience working with regulated framework such as GLP 17, MHRA data integrity and ISO 17025. • Demonstrated experience in quality assurance, quality control laboratory, product testing, regulatory and clinical process. • Past experience with cloud technologies such as laaS, PaaS, SaaS and agile methodologies would be an asset. • Sound working knowledge of quality management system, project management and SDLC. • Excellent communicator with a result-oriented mindset. • Proven ability to coach, action driven and business acumen. • Fluent in English both oral and written. 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.

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