Main responsibilities and activities
In the Quality Department we are looking for a brilliant profile reporting to the Site Quality Head with the following responsibilities and activities:
Ensures that the organization’s Quality Management System is fully applied within the area of responsibility maintaining total compliance to current GMP, GDP, Data Integrity requirements.
Behaves according to company Ethical Code and company values.
Ensures the correct approval, authorization and archiving of all documentation of relevant to Quality Assurance activities.
Ensures the implementation of corrective actions resulting from inspections by external entities (authorities, customers, etc.).
Ensures the execution of periodic reports (Annual Product Review) on products manufactured in the plant.
Plans and ensures execution of the GMP training at the plant and monitor qualification and continuous training of site personnel involved in GMP activities.
Collaborates for tracking, trending and reporting of Quality Metrics for site.
Ensures adherence to Italian and EC laws relevant to the production and release on the market of API and pharmaceutical ingredients and any specific country requirements as established by Italian Ministry of Health and AIFA.
In collaboration with the SQH and other segments of Quality Assurance, ensures that the organization’s Quality Management System is fully applied within the area of responsibility maintaining total compliance to current GMP, GDP, Data Integrity requirements.
Ensures that the Environmental, Hygiene, Safety and High Risks Prevention Management System is fully applied within the area of responsibility maintaining compliance to current requirements.
Behaves according to company Ethical Code and company values.
In front of Italian Government, responsible person for compliance with all cGMPs and industrial activities which could affect, to any extent, the quality of the products produced.
Ensures that each API lot is produced and tested according to the laws in force “Decreto Legislativo 219/06”, the cGMP and conditions set in the production license.
Responsible for the release of final product, testing, storage, manufacturing compliance with master formulas and cGMPs. In this respect is responsible for approval of master batch cards.
Requirements
Education/Other Essential Requirements:
University degree in accordance with legal requirements or – preferred – University degree in Chemistry, Pharmacy or CTF
Authorization by AIFA as Qualified Person
Skills:
Ability to work cross-functionally
Strong Change Management capabilities
Strong Project Management
Familiar with Quality IT Systems: i.e. TrackWise
Experience in Inspection management
Languages: Proficient English and Italian
Minimum Experience: 5 years work experience in Quality Assurance and experience in Quality Control .
