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PMI Service Center Europe
PMI Service Center Europe
location iconLocations: Kraków
level iconLevel: specialist
APPLY AS
QA Engineer (FDA)
Location: Kraków

MAKE HISTORY WITH US!

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.


JOIN US!

WHO ARE WE LOOKING FOR?

• College/University degree, preferably in Quality Management, Chemistry, Chemical Engineering, or similar
• At least 5 years of experience in regulated industry: pharmacy, medical devices, food
• Experience in FDA inspection/MOCK inspections using front and back office techniques, preferably for FDA CFR 820 and part 11 compliance.
• Preferred expertise in Risk Management (e.g. ISO 14971), CAPA, V&V,CSV, Data integrity and DMR/DHR/DHF, design transfer
• Experience in internal, external and supplier auditing including special processes auditing: formulation, injection molding, ultrasonic welding, mixing.
• Fluent English that enables professional communication with native speakers
• An individual able to give direction for the colleagues and managers in the scope of quality assurance requirements
• Decision making person ready to take risks to assure area development and understanding business impact
• Team player with ability to cooperate with colleagues from different department such as production, project management, quality control etc.

WHAT WE OFFER YOU?

• Cafeteria with various benefits
• attractive medical care for you & family
• on-site medical facility for employees
• pension employee program
• free car & bike parking
• subsidized meals in company canteen;
• flexible working arrangements;
• wide range of trainings, optional language classes, further education and professional qualification support possibility

HOW CAN YOU MAKE HISTORY WITH US?

• Supporting in building quality system that is effective enough to satisfy FDA requirements for new Reduced Risk Products
• Develop knowledge and awareness for PMI employees to increase quality of products, processes and system by trainings and by example.
• Judging effectiveness of corrective actions implemented on products and processes
• Being a partner in discussions with R&D and other central functions
• Running critical meetings: Management Review, CAPA committee, Change Committee, Supplier Qualification committee
• Assessing capabilities of processes to constantly meet quality requirements
• Creating presentations, reports and summaries to spread the requirements within all level of organization.

Please note that only on-line applications will be taken into consideration.
Only selected candidates will be contacted.

Details

  • iconIT, Engineering
  • iconKraków, małopolskie

Company profile

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