Corporate QA Senior Specialist
1 mese fa
About usBased 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: Discover more hereWe 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 DivisionChiesi 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.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 SkillsProactiveness
Adaptability and flexibility
Communication skills
Quality orientation
What 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.
-
Corporate Qa Senior Specialist
2 mesi fa
Parma, Italia Chiesi Group A tempo pienoWho 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.-...
-
Corporate QA Senior Specialist
2 mesi fa
Parma, Italia Chiesi Group A tempo pienoWho we are looking for 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...
-
Corporate QA Senior Specialist
7 giorni fa
Parma, Emilia-Romagna, Italia Chiesi A tempo pienoAbout UsChiesi is a leading international pharmaceutical and healthcare group with a rich history of innovation and commitment to excellence. With over 85 years of experience, we operate in 31 countries and employ over 7,000 talented individuals worldwide.Our MissionWe strive to improve people's quality of life by acting responsibly towards society and the...
-
Corporate Qa Senior Specialist
1 mese fa
Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoSelect how often (in days) to receive an alert: 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...
-
Corporate Qa Senior Specialist
1 mese fa
Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoSelect how often (in days) to receive an alert: 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...
-
Corporate Qa Senior Specialist
1 mese fa
Parma, Italia Chiesi A tempo pienoAbout usBased 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,...
-
Corporate Supply Chain Specialist
1 settimana fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoJob SummaryWe are seeking a highly skilled Corporate Supply Chain Specialist to join our team at Chiesi Group. The successful candidate will be responsible for managing S&Op processes for material availability in the short-mid term, collaborating with Procurement, Industrialisation, Quality, and Sites Planning.Key ResponsibilitiesProcess Management: Analyze...
-
Corporate Supply Specialist
3 mesi fa
Parma, Italia Chiesi Group A tempo pienoWho we are looking forPurposeThe Corporate Supply Specialist, being part of the Corporate Supply Chain department, interacts and collects inputs from functions such as Procurement, Industrialisation, Quality and Sites Planning to coordinate the S&Op processes in terms of requirements and supply granting the material availability in the short-mid term.Main...
-
Corporate Supply Chain Specialist
7 giorni fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoAbout the RoleWe are seeking a highly skilled Corporate Supply Chain Specialist to join our dynamic team at Chiesi Group. As a key member of our Corporate Supply Chain department, you will play a crucial role in coordinating the S&Op process, ensuring the material availability in the short-mid term.Main ResponsibilitiesCoordinate the S&Op process in terms of...
-
Corporate Supply Specialist
3 mesi fa
Parma, Italia Chiesi Group A tempo pienoWho we are looking for Purpose The Corporate Supply Specialist, being part of the Corporate Supply Chain department, interacts and collects inputs from functions such as Procurement, Industrialisation, Quality and Sites Planning to coordinate the S&Op processes in terms of requirements and supply granting the material availability in the...
-
QA Validation Specialist
3 mesi fa
Parma, Italia Amaris Consulting A tempo pieno**Who are we? **:**Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7,600 people spread across 5 continents and more than 60...
-
QA Validation Specialist
3 mesi fa
Parma, Italia amaris A tempo pienoJob description QA Validation Specialist Cosa farai? Ti inserirai all'interno del team di Quality Assurance, nella divisione Validazioni. Garantire il rispetto delle linee guida normative e degli standard GMP. Eseguire attività di validazione di processo produttivo per azienda farmacautiche. Sviluppare ed eseguire protocolli di validazione. Eseguire...
-
Corporate Quality Assurance Specialist
5 giorni fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoMain ResponsibilitiesWe 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...
-
Corporate Quality Assurance Specialist
6 giorni fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoMain ResponsibilitiesWe 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...
-
Global R&D Qa- Pv Compliance Specialist
3 mesi fa
Parma, Italia Chiesi Group A tempo pienoChi siamoChiesi Italia, filiale italiana del Gruppo Chiesi con sede a Parma, è da sempre impegnata nelle attività di informazione medico-scientifica, commercializzazione e distribuzione dei prodotti Chiesi sul territorio italiano.La visione, le competenze e l'impegno per migliorare la salute e la qualità di vita di pazienti e caregiver si concretizzano...
-
Corporate Auditor
3 mesi fa
Parma, Italia ATS Corporation A tempo pieno**Job Profile**: Position Title: Corporate Auditor Department: Corporate Audit Reports to: Audit & Compliance Manager / Senior Corporate Auditor **Job Summary**: Internal Audit's purpose is to support the board and senior management in protecting ATS' assets, reputation, and sustainability by challenging the controls framework's effectiveness, which enables...
-
Corporate Auditor
3 mesi fa
Parma, Italia ATS Corporation A tempo pieno**Job Profile**: Position Title: Corporate Auditor Department: Corporate Audit Reports to: Audit & Compliance Manager / Senior Corporate Auditor **Job Summary**: Internal Audit's purpose is to support the board and senior management in protecting ATS' assets, reputation, and sustainability by challenging the controls framework's effectiveness, which enables...
-
Corporate Supply Specialist
3 mesi fa
Parma, Italia Chiesi A tempo pienoAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group...
-
Corporate Supply Specialist
7 giorni fa
Parma, Italia Chiesi A tempo pienoAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 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,...
-
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoIdeal Candidate Profile Key Responsibilities Oversee the management of products and projects associated with the respiratory sector, focusing on both qualitative and analytical assessments. - Collaborate with various departments at both local and corporate levels, engaging with R&D, regulatory bodies, and external consultants. - Assist in the...
