Durata: 6 mesi
Location: Roma o Milano
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
- Preferable Master Degree in Pharmacy or Chemistry or Chemical and Pharmaceutical technologies
- Good knowledge of English.
- Knowledge of Microsoft Office (Excel, Word, Outlook, Access).
- Experience with ISO 9001 and 13485 standards is an advantage.
- Knowledge of GMP and/ or GDP guidelines is an advantage.
- Experience in business communications.
- Ability to prioritize decisions.
- Identify potential gaps in the processes and make recommendations for possible improvements.
- Able to work within time-limits (deadlines), persistent Some travel may be required