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QA Systems Specialist

3 mesi fa

Varese, Lombardia, Italia Grünenthal A tempo pieno

Country:
Italy
City:Origgio (Varese)
Department:Global Operations & Production
Job ID:44182
QA Systems Specialist

  • We are looking for a
    QA Systems Specialist for the production plant in
    Origgio (VA, 30 km from Milan).
  • If you are a dynamic person with a problemsolving mindset, who wants to work in an international environment and are willing to support the growth of our business, you will feel in the right place for your next career move.

Your main tasks as QA Systems Specialist will be:

  • Contribute to compliance, robustness, continuity and operational excellence of GMP Quality System at the local Manufacturing Site;
  • Design and run QMS processes at the Manufacturing Site; act independent and interchangeable in the management of QMS processes
  • Support operational departments in implementation and maintenance of QMS tools
  • Responsible for reporting QMS processes during Authorities Inspections and Third parties Audits
  • Contribute to QA or Site projects
  • Support Qualification and Validation activities
  • Quality KPI tracking and reporting
  • Degree in natural sciences, e.g. Pharmacy, Chemistry
  • Businessfluent/native in Italian and Businessfluent English.
  • Very good knowledge of pharmaceutical manufacturing processes and applicable regulations.
  • Act with integrity and consistency, with ethical approach granting always quality oriented focus.
  • Sound understanding of cGMP and experience in successful improvements of Quality Management System.
  • Experience in planning, hosting, execution and followup of audits and inspections
  • Strong knowledge of pharmaceutical regulations and guidelines applicable in EU and US.
  • Excellent stakeholder management & networking.
  • Leading change, Inspires and motivates others.
  • Patient safety orientation.
  • Strong interpersonal understanding & communication skills.
  • Location: Origgio (VA)Grünenthal offers equal employment opportunities. Recruitment will take place without distinction with regard to religion, gender, sexual orientation, age, origin, disability or other relevant categories.