Who we are looking forMain Responsibilities- Be in charge of managing products/projects related to the respiratory area from both a qualitative and analytical point of view.- Collaborate with other functions both locally and at Corporate level (other production sites/affiliates), also interfacing with R&D, regulatory functions and external consultants.- Cooperates in the implementation of guidelines for system and process validation activities in compliance with the requirements of National and International GMP regulations.- Supervises validation activities at Chiesi sites by evaluating data and defining corrective actions with local teams.- Collaborates in the drafting and preparation of validation documents relating to Corporate products and/or new lines/departments at Chiesi production sites.- Manages change control and deviations relating to Corporate products/processes.- Provides support, where necessary, in the following strategic planning activities of the Industrial Management: o Scenario analysis; o Business continuity risk analysis; o Definition of the insourcing / outsourcing strategy in the industrial area;- Contributes to the drafting of Technical Agreements, when defining them with suppliers of materials and services.- Provides support in the definition of industrialisation programmes for new products or the implementation of new production processes for products already on the market.Experience RequiredAt least 6-8 years of experience in Quality Assurance in the pharmaceutical industry.EducationDegree in Chemistry, Industrial Chemistry, CTF, Biotechnology, Biology or equivalent.Languages- Fluent knowledge of the English language;- Knowledge of the French language will be considered a plus.Technical Skills- Excellent knowledge of international pharmaceutical legislation (in particular CFR tit21 and European directives) and international regulatory references (FDA, EMEA, ICH) concerning the production, control and distribution of drugs, the main international pharmacopoeias and GMP (EU, USA, PICs, WHO).- Knowledge of Total Quality Management standards and principles;- Knowledge of management information systems (ERP);- Knowledge of suppliers and subcontractors in the Italian and possibly European sphere, with particular reference to manufacturers of active ingredients and excipients for pharmaceutical use;- Knowledge of Risk Management, Auditing and Training techniques.Soft SkillsProactivenessAdaptability and flexibilityCommunication skillsQuality orientationWhat we offerYou would join a dynamic, fast-growing, challenging and friendly environment.In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development.
Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best.
That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.