Publication date: 07 Apr 2019

CSV Validation Lead for SAP

Philip Morris International Service Center Europe

Language:

Category: Engineering

Level of English: C1-C2

Position level: Specialist

APPLY AS

CSV Validation Lead for SAP

Location: Kraków

 

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:

CSV Validation Lead for SAP

With the following requirements:

• University degree in Life Science, Engineering or equivalent
• Seasoned experience in computerized system validation preferably in pharmaceutical industry
• Strong knowledge on GLP, GCP, GMP, 21 CFR part 11 and GAMP5 would be an asset
• Good understanding of Enterprise Resource Planning (ERP), but in particular with SAP system
• Proven experience of CSV activities on SAP
• Good understanding of Product Lifecycle Management (PLM) and Manufacturing Execution System (MES)
• Proven experience with CSV in the Consumer Packaged Goods industry with a good understanding of batch management principle, data structure & modeling and PLM or MES validation
• Demonstrated ability to communicate, present and influence credibly and effectively at all levels of the organization
• Strong problem solving and organizational capabilities coupled with proven leadership skills
• Strong reputation in engaging in proactive behavior and seizing opportunities
• Fluent in English both written and spoken

If you possess the above mentioned profile then you are the one we want to meet for staffing our IS Quality – Affiliate deployment Team, within the IS Quality department, in Philip Morris Krakow, Poland.

As a Validation Lead you will be responsible to lead the validation of products computerized systems during project as well as run and support phase. You will as well support the business partners in all GxP related decisions, including the compliant, safe, reliable and consistent operation of the computerized system.

Your specific responsibilities will be to:
• Define, document and maintain the risk assessment of new and existing system to support risk based validation approach.
• Perform the QA reviews on documentation produced by the validation engineers and SMEs as per the QMS.
• Perform QA review of data governance documentation which are produced prior the projects to document data flow and conceptual data model supporting risk analysis of the envisaged systems.
• Participate in the development and improvement of QMS procedures and practices for CSV and DI for the area of responsibility.
• Ensure the strategy of validation is defined and followed

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

Check PMI SCE profile


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