Senior AIR Engineer (Always Inspection Readiness)

Senior AIR Engineer (Always Inspection Readiness) 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. Your ‘day to day’ As Senior AIR (Always Inspection Readiness) Engineer, you will be part of Global Quality Compliance department for Philip Morris International and will be reporting to the Manager AIR Quality Compliance. The position will be based in Crespellano (Italy). In this role you will oversee, control and coach adherence to Quality Management System (QMS) to increase inspection readiness, compliance and drive elevation of maturity level. Assess and assist critical stakeholders in quality compliance aspects A key responsibility will be lead review of NC/CAPA/Changes, ensuring quality of records, effectiveness of action planned and timely reporting of KPI and documents. Additionally, you will oversee delivery of action plan, response plan and training. Finally, you will advocate, promote and transfer know-how and coach on guiding principle on inspection readiness and quality compliance. More specifically, you will: • Inspection Readiness Model deployment execution in different locations/sites o Review of critical quality records, perform compliance checks (NC/CR/Audit Findings/Complaints/Recall) & Provide guidance on NC, Change, CAPA and Exception Management o Verify and ensure quality of records, effectiveness of remediation o Verify Review of documentation to be sent to Regulatory Bodies (Submission of full Package/Annual Report/Inspection Response/ and related correspondence) o Support interaction with regulatory authorities to ensure successful regulatory inspection o Support strategy for effective QMS deployment and for building PMI quality culture and capabilities o Identify applicability of findings for other PMI entities o Coordinate reporting and follow-up on open NC/CAPA/changes o Ensure execution of selected escalated NC/CAPA/changes • Drive increase of Inspection Readiness Maturity Level for selected entities and identify need of the transfer of know-how and knowledge accordingly o Define Role & Responsibility o Identify SME, define knowledge gap and coach o Collect and verify checklist for inspections. o Drive planning and execution of response to audits findings • Various support to AIR Quality compliance Manager o Advise on critical points of attention o Authoring SOP and wiki o Participate to risk assessment and definition of Maturity level o Propose and implement process improvement (incl. systems) o Prepare process description and training Who we are looking for: • University degree in Engineering, Chemistry or related field • Substantial experience in Quality Assurance in pharmaceutical industries or medical device industries and GXP controlled environment • Profound knowledge in FDA, US GXP and EU regulations relevant for audit/inspections, qualification/validation, compliance systems • Excellent communication, project management and decision making skills • Proficient in providing solutions for complex challenges • Ability to work independently in a team environment • Past experience in working within a cross-functional, multidisciplinary and project team oriented environment to ensure project and business alignment • Fluent in English, both written and spoken. WHAT WE OFFER Permanent Contract Relocation package offered 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. We are a leading international tobacco company engaged in the manufacture and sale of cigarettes and other nicotine-containing products in markets outside the United States of America. We are building our future on smoke-free products that are a much better consumer choice than continuing to smoke cigarettes. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, we aim to ensure that our smoke-free products meet adult consumer preferences and rigorous regulatory requirements. Our vision is that these products ultimately replace cigarettes to the benefit of adult smokers, society, our company and our shareholders. For more information, see our PMI and PMI Science websites. Philip Morris Manufacturing & Technology Bologna is Philip Morris International's first center for personnel training and prototyping, industrialization, and large-scale production of potentially reduced risk products (RRPs). ...