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QA Change Management & Risk Management Specialist

Primary Location WARSZAWA, Polska Job ID R23040829

Sprawdź swoją kolejną możliwość w organizacji z listy Fortune Global 500. Wyobraź sobie innowacyjne możliwości, poznaj naszą satysfakcjonującą kulturę i pracuj z utalentowanymi zespołami, które pomagają Ci stawać się lepszą wersją siebie każdego dnia. Wiemy, czego potrzeba, aby wprowadzić UPS w przyszłość – ludzi z wyjątkowym połączeniem umiejętności i pasji. Jeśli masz odpowiednie cechy i motywację, aby kierować sobą lub zespołami, istnieją stanowiska, dzięki którym rozwiniesz swoje umiejętności i wzniesiesz się na wyższy poziom.

Opis stanowiska:

As QA Change Control and Risk Management Specialist for the Quality Support Center (QSC) you’ll assist sites located globally with the creation and maintenance of change controls and Quality Risk Management programs in alignment with UPS Healthcare Quality Managment System and application Healthcare regulations (e.g., cGMP, GDP, ICH, and ISO 9001/ISO 13485 requirements.Additionally, you’ll be responsible for the creation of reports and follow up on open items related to applicable change controls and/or risk records.

In this role, you will communicate change controls and/or quality risk concerns identified at the QSC to the next level of management.

Responsibilities:

  • Assist in development and implement a comprehensive global change control strategy for GxP compliance across all relevant functions and regions
  • Assist in the development and implementation of quality systems “how to” for quality support center for control, change control
  • Monitors and provides direction to the team for compliance against UPS Healthcare site/ country regulatory requirements (e.g., GMP, GDP) to internal departments on change controls
  • Lead coordination, Initiates, assesses, and documents change controls and risk records (if applicable) within in the electronic Quality Management System (eQMS)
  • Follow up with internal and external stakeholders on all open items related to change controls or risk records within in the eQMS.
  • Escalates risks , presents risk assessment report, and makes recommendations to the next level of management
  • Tracks action plans to closure and reports late/delayed action plans to the next level of management
  • Provides data and supports quality management system reviews for area(s) of responsibilities

Qualifications:

  • Education: minimum of a Bachelor’s degree with Good knowledge of English.
  • Knowledge of electronic Quality Management System is an advantage.
  • Knowledge of Microsoft Office (Excel, Word, Outlook, Access).
  • Experience with global healthcare regulations (e.g., cGMP, ICH, GCP, GDP) guidelines is preferred.
  • Experience with ISO 9001 and ISO 13485 standards is an advantage.
  • Availability to work 100% time from the office (Warsaw)


Typ pracownika etatowego:

Stały


UPS dokłada wszelkich starań, aby zapewnić miejsce pracy wolne od dyskryminacji, nękania i działań odwetowych.