Job Description

Validation Lead

Are you up for a new challenge? Do you look for ways to grow in your job? And do you want to build a remarkable career? Then apply now! We are currently looking for a: Validation Lead As a Validation Lead, you will lead PMI’s computerized system validation project approach and establish the validation strategy of computerized systems, including assessment and delivery of all validation deliverables. You ensure validation maintenance of GxP systems within your defined scope. You will also ensure the training of project team members and users of the system in the context of computerized systems validation and data integrity. Your specific responsibilities will be: • Define, document and maintain the risk assessments for implementation of new systems and changes to existing GxP systems to support a risk based validation approach • Establish validation/qualification plans & validation/qualification reports of different projects • Perform QA review of validation deliverables • Participate in the development and improvement of QMS procedures and practices for CSV • Advise project managers and IS system service managers on validation activities in a timely manner • Train and coach on the validation or qualification practices related to CSV We’re currently looking for a: Validation Lead CSV) With the following requirements: • University degree in Engineering, IT, Science or equivalent • Information System and business experience would be an asset • Solid understanding of regulated life sciences industry processes (deep knowledge of 21 CFR Part 11, Annex 11, GAMP5, ITIL, etc.) from early research to industrial manufacturing (process mapping, data governance and architecture, traceability). • Proven (5+ years) experience leading computerized system validation and IT qualification of GxP systems in a regulated life sciences industry • Experience in writing and reviewing validation and qualification deliverables related to CSV of GxP systems • Strong problem solving, solid communication and interpersonal abilities as well as proven leadership and organizational savvy • Excellent communication skills and fluency in English If you possess the above mentioned profile then you are the one we want to meet for staffing our Information Systems Quality Department, within the ISQ - Infrastructure team in Philip Morris SCE, based in Krakow, Poland. Why work for us? • We’re international: you work with clients and learn on-the-job from team members from all over the world; • We’re flexible: your work fits you and not the other way round, thanks to our Flexible Work Arrangement Program; and • We’re a certified top employer: we consider our employees to be our strongest asset, and we are developing talent throughout all levels of the organization. WE OFFER • private medical care together with dental care • subsidized meals • remote work opportunity • optional company kindergarten • life and disability insurance • employee pension program • multisport program • leave and holiday benefits • further education and professional qualification support • cultural benefit • social aid • gifts for life events • discounter program JOIN A GLOBAL MARKET LEADER Philip Morris International: Building a Smoke-Free Future Philip Morris International (PMI) is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes to the benefit of adults who would otherwise continue to smoke, society, the company and its shareholders. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes, smoke-free products and associated electronic devices and accessories, and other nicotine containing products in markets outside the U.S. PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements. PMI's smoke-free IQOS product portfolio includes heated tobacco and nicotine-containing vapor products. As of September 30, 2018, PMI estimates that approximately 5.9 million adult smokers around the world have already stopped smoking and switched to PMI’s heated tobacco product, which is currently available for sale in 43 markets in key cities or nationwide under the IQOS brand. For more information, see our PMI and PMIScience websites. If you wish to contribute to the future of our business and to the new scientific journey of the industry, please apply online. PMI is an Equal Opportunity Employer FIND A NEW PATH Our company offers you a fresh perspective. Here, you will never stop exploring and discovering. We take on-the-job learning to another level, giving you every opportunity to develop your career and reach your full potential. With innovative technologies, services, and processes, backed by a competitive salary and benefits, you will work in a professional setting with clients and team members from all over the world. Apply on-line in English at www.pmicareers.pl
  • Contract
  • Location
    Krakow, Poland
  • Department
    Science & Innovation
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