Corporate Quality Assurance Specialist
6 giorni fa
We are seeking a highly skilled Corporate Quality Assurance Specialist to join our team at Chiesi Group. The successful candidate will be responsible for managing products/projects related to the respiratory area from a qualitative and analytical perspective.
Key responsibilities include:
- Collaborating with other functions both locally and at Corporate level, interfacing with R&D, regulatory functions, and external consultants.
- Implementing guidelines for system and process validation activities in compliance with National and International GMP regulations.
- Supervising validation activities at Chiesi sites by evaluating data and defining corrective actions with local teams.
- Drafting and preparing validation documents relating to Corporate products and/or new lines/departments at Chiesi production sites.
- Managing change control and deviations relating to Corporate products/processes.
- Providing support in strategic planning activities, including scenario analysis, business continuity risk analysis, and definition of the insourcing/outsourcing strategy in the industrial area.
- Contributing to the drafting of Technical Agreements with suppliers of materials and services.
- Supporting the definition of industrialisation programmes for new products or the implementation of new production processes for products already on the market.
At least 6-8 years of experience in Quality Assurance in the pharmaceutical industry.
EducationDegree in Chemistry, Industrial Chemistry, CTF, Biotechnology, Biology, or equivalent.
LanguagesFluent knowledge of the English language; knowledge of the French language will be considered a plus.
Technical SkillsExcellent 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, management information systems (ERP), suppliers and subcontractors in the Italian and possibly European sphere, with particular reference to manufacturers of active ingredients and excipients for pharmaceutical use, Risk Management, Auditing, and Training techniques.
Soft Skills- Proactiveness
- Adaptability and flexibility
- Communication skills
- Quality orientation
You would join a dynamic, fast-growing, challenging, and friendly environment. We believe that our people are our most valuable asset, and we invest in continuous training, learning, and development. We strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and 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.
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