Corporate QA Senior Specialist
2 meses atrás
Department: Corporate Quality Operations
Job Type: Direct Employee
Team: Quality
Contract Type: Permanent
Location: Parma, IT
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas.
We are proud to have been awarded with B Corp Certification , a recognition of high social and environmental standards . We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.
We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors . Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
Chiesi Global Manufacturing Division
Chiesi Group has three production plants: Parma (Italy); Blois-La Chaussée-Saint-Victor (France); Santana de Parnaíba (Brazil). The plants produce a total of over 110 million units per year.
The production plant in Parma covers a total area of more than fifteen thousand square meters and it is the strategic hub for the production and distribution of our products, being an international supply center that exports to more than 80 countries. The Parma plant produces solid medicinal products, such as tablets and inhaled dry powders; inhalation solutions and suspensions, either pressurized or sterile single-dose vials; vials of sterile suspension for endotracheal administration; liquid forms such as drops, syrups and nasal sprays.
Santana produces pressurized solutions and suspensions for inhalant therapy (MDIs) and supplies both domestic market and Group’s Affiliates and exports to licensees and distributors. Blois specializes in Dry Powder Inhalers and final assembly stages of the Metered-Dose Inhalers (MDIs), supplies Group’s Affiliates and distributes directly to clients at a local level and in export markets.
Main 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.
At 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.
- 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.
- Adaptability and flexibility
- Quality orientation
What we offer
You 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.
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