Main responsibilities and activities
In the Santhià Quality Department we are looking for a brilliant profile reporting to the Site Quality Head with the following responsibilities and activities for the microbyological analysis of all the Italian TAPI sites (Caronno, Villanterio, Rho and Santhià):
Manage Data
Responsible for review and approval of experimental data provided by microbiological tests on raw materials and finished products and on environmental controls.
Responsible for Analytical Documentation.
Manage microbiological analytical data
Guarantees the compliance of microbiological analytical data generated with cGMP requirements.
Supports the QA/Qualified Person about the redaction of SOPs, analytical monographs, validation documentation and all other procedures and activities which could affect, to any extent, the microbiological final product quality.
Supports the QA/Qualified Person
To manage the audits of Customers and Health Authorities and written and verbal Responses.
To qualify the new suppliers.
To plan the yearly Microbiological Quality Control budget.
To organize internal professional update courses.
Management of people
Complying with the Human Resources Policies, the role improves motivation and professional competence of employees.
Requirements
Main requirements:
Ensure that organization’s Quality Management System is fully applied within the area of responsibility maintaining total compliance to current GMP, GDP, Data Integrity requirements.
Ensure adherence to environment, health and safety company requirements as well as legal obligations.
Behave according to company Ethical Code and company values.
Education:
Biology University Degree or equivalent Degree
Languages:
English (level of proficiency)
Local language capability in order to communicate to all levels in the sites
Experience:
Minimum: 5 years in microbiological analyses.
