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PMI Service Center Europe
PMI Service Center Europe
location iconLocations: Kraków
level iconLevel: specialist
time iconWorking hours: Full time
APPLY AS
Senior Quality Compliance Auditor
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.

As a Senior Quality Compliance Auditor, you will ensure effective deployment / application of the Audit Management Processes and Quality Management System (QMS) and related tools, collaborate to role-model Quality at source, lead audit to support successful Competent Authority inspections/audits and improve compliance, collect, consolidate audit data, analyse and ensure effective use of these data, train and act as interface between Quality Compliance Audit and the function / organization.

JOIN US!

WHO ARE WE LOOKING FOR?

• Bachelor’s or Master’s Degree in technology, science, engineering or equivalent
• Demonstrated audit experience in Manufacturing, ISO, GMP in the pharmaceutical, food and/or FMGC industries; FDA experience is a plus
• Good Knowledge of Quality Standards and Management Systems in ISO 9001, ISO 17025, GMP and/or GxP, as well as expertise working with audit management tools
• Sound project management, leadership, communication and interpersonal skills
• Fluent in written and spoken English; other languages would be an asset

WHAT WE OFFER YOU?

• Private medical and dental care, life insurance
• Subsidized meals in company canteens or Sodexo card while working remotely
• Company car / or car allowance
• Remote work opportunity and flexible working arrangements
• Employee pension plan
• Multisport program
• Cafeteria program with various benefits
• Wide range of trainings, optional language classes, further education and professional qualification support possibility
• Free bike and car parking for all employees

HOW CAN YOU MAKE HISTORY WITH US?

• Establish annual Global Audit Programme based on risk analysis, support Coordinators and Leaders, process / monitor organization related changes, and ensure reporting of results
• Plan, coordinate and execute, verify adherence with the QMS processes and regulatory requirements and standards, raise critical observation to Management, issue and distribute report to auditees and Quality Management, evaluate team performance, and update audit status upon completion
• Conduct follow-up and verify efficiency of the actions agreed with the auditees, review, approve or reject actions proposed, verify completion with supporting evidence, update documentation incorporating responses received
• Implement related QMS to ensure improvement of the process including practices related to the remote auditing, maintain package aligned with the Management Tools, and related documentation
• Supervise Auditor Pool and Competencies to ensure qualification, expertise availability, define / update materials and organize audit related trainings
• Monitor and report objectives / results related to processes, ensure adherence, issue status report and provides justification for the discrepancies, raise to the Management critical findings from Competent Authority
• Support Business Process Owner, community in understanding the processes and use of the tools, coordinate valuable processes and implement these, monitor and support changes impacting the functionalities
• Perform mock inspection audits to ensure ongoing readiness of the organization, collaborate with other coordinators to ensure documentation is submitted/published in a timely manner, and support ready state of the site to be inspected


Details

  • iconAnalytics & Reporting, Audit
  • iconEnglish
  • iconKraków, małopolskie

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