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Quality Sr. Admin

Primary Location: Via Formellese, Km. 4.300 , Formello, Roma - IT, 00060 Job ID 061024

JOB PURPOSE AND KEY RESPONSIBILITIES

Assist with the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and 13485 standards, and in compliance with the EU GMP and EU GDP Guidelines.

Provide support for investigation into non-conformances and customer complaints.

Maintenance and Follow-up on Corrective Actions and Preventive Actions (CAPAs).

Provide the trainings and coordinate the trainings for the staff.

Registration of the trainings into the electronic Quality Management System (eQMS) and running of reports.

Assist with the documentation review after an operational activity.

• Collection of Temperature Data and Monitoring of the temperature environmental conditions.

• Reporting of day-to-day activities.

Take care of and communicate with internal and external contacts.

Control administrational aspects of the facility (e.g. archiving).

Promote a “quality” culture within the company.

KNOWLEDGE AND EXPERIENCE

Education level:

oPreferable Master Degree in Pharmacy or Chemistry or Chemical and Pharmaceutical technologies

oGood knowledge of English.

oKnowledge of Microsoft Office (Excel, Word, Outlook, Access).


Specialized Knowledge:

oExperience with ISO 9001 and 13485 standards is an advantage.

oKnowledge of GMP and/ or GDP guidelines is an advantage.

oExperience in business communications.

• Skills:

oAbility to prioritize decisions.

oIdentify potential gaps in the processes and make recommendations for possible improvements.

oAble to work within time-limits (deadlines), persistent

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