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 one clear purpose - to deliver a smoke-free future. 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. Wherever you join our crucial 47,000-strong Operations team, you'll have the opportunity to make an impact. PMI's shift from selling cigarettes to our new smoke-free products has changed the way we work. New products bring new challenges - in the way we source and buy raw materials, in the way we engineer and manufacture, and in our supply chain planning. Bring us your curiosity and a desire to challenge the everyday and we'll give you lots of responsibility. You'll help us improve, inject innovation and create new ways of working. You'll be solving supply chain problems that span the whole world: a smoke-free world. 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. - Insure that projects plan and change management activities are properly scheduled and are adequately staffed. Perform & document Risk Assessment - Document risk assessment of systems and propose validation recommendation - Document and register systems Lead Computerized System Validation - Define validation approach (Validation plan) - Train validation SME - Support and coach validation SME - Deliver validation report Control Validation documentation - Perform Quality review of SME documentation produced to support the system validation. - Manage deviation, and CAPA Liaise with IT / Business stakeholder to optimize validation effort - Define workload of requested validation activities - Advice on technical solution to reduce validation effort - Optimize systems changes management - Support test automation strategy and Agile approach" Coordinate Computerized Systems Validation for manufacturing deployment of Asia - Single Point of contact for CSV - Change Management main contact point - Training validation SME EMS Support for ASIA region for CSV & DI - Single Point of contact for CSV related question - SME during audit of critical EMS Who we're looking for - Bachelor degree in Technology / science / engineering or equivalent - 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) Regulatory Framework - GCP, GLP and GCLP - FDA, 21 CFR part 11. - ISO 17025 Process - Product Life cycle and - Laboratories processes - Manufacturing - Quality Control Laboratory - Engineering Good Practices & IT - GAMP 5 - ITIL, COBIT - Quality Management Systems - Experience with cloud technologies (IaaS/PaaS/SaaS) would be an asset - Experience with agile methodologies would be an asset - SDLC and project management knowledge would be an asset Technical skills: Experienced in writing main validation delivarables such as Validation plan and Report LIMS and Clinical systems knowledge would be an asset Soft skills: Communication, negotiation, ability to coach, Business acumen, deal with ambiguity, managerial courage, result oriented, project management Language: English - Fluent or morther tongue What we offer Our success depends on our talented employees who come to work here 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 deliver a smoke-free future. To join our growing team
