- 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.
- University degree in accordance with legal requirements or – preferred - University degree in Chemistry, Pharmacy or CTF
- Authorization by AIFA as Qualified Person
- Ability to work cross-functionally
- Strong Change Management capabilities
- Strong Project Management
- Familiar with Quality IT Systems: i.e. TrackWise
- Experience in Inspection management
- Ticket Restaurants for each working day, smartworking days included
- Working flexibility for Caregivers and parents
- Recognition Program
- Welfare Platform
- Flexible working environment
- Highly inclusive and multicultural working environment
- Continuous learning and development programs (with full access to Linkedin Learning)
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QA Manager e QP - Caronno Pertusella, Italia - Teva Pharmaceuticals
Descrizione
Who we are
Teva, world leader with over employees, in the field of equivalent medicines, with a differentiated business that also includes specialist medicines, over-the-counter drugs and the production and marketing of APIs (active pharmaceutical ingredients), is present in Italy for over 25 years with a commercial branch and manufacturing sites.
Our mission is simple: improve the wellbeing of our patients.
We care about them and about our colleagues, creating a respectful, diverse and inclusive working environment, committing ourselves to maintaining high standards of quality, compliance and safety, always respecting our values:
We all work for one company and we work together to achieve a common goal.
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:
Requirements
Education/Other Essential Requirements:
Skills:
Languages: Proficient English and Italian
Minimum Experience: 5 years work experience in Quality Assurance and experience in Quality Control .
What we offer?
We try to take care of our employees, offering them small and large benefits. By way of example:
Type of contract: long term contract
Location and working program
Caronno (VA) from Monday to Friday.
Teva's commitment to equal opportunities
Teva is committed to equal opportunities in the world of work. Our global policy requires equal employment opportunities to be provided regardless of age, race, religion, health, identity, gender expression, protected categories or any other legally recognized status that is entitled to protection under applicable laws.