Global Process Validation Sme
4 ore fa
**Date**:Aug 29, 2024**Department**:Corporate Products Industrialisation**Job Type**:Direct Employee**Team**:Industrial Operations & HSE**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**:Discover more here**
- 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.**_Who we are looking for_**
**Purpose**
- The figure will act as a Subject Matter Expert of Process Validation and technical maintenance activities within the Corporate Products Industrialization department and will interface with internal and external stakeholders as R&D, Operations and contract manufacturers/subcontractors. He/She will be responsible for coordinating of maintenance activities on in-market products (pMDI).
**Main Responsibilities**
- Act as point of contact for Global Manufacturing functions (incl. plant Site Process SME) on technical expertise for maintenance activities for in-market products, regarding maintenance needs collection, planning and execution, challenges identification and reporting to dedicated governance bodies, including plant Site Process SME (Chiesi sites & CMO);
- Act as point of contact for root cause analysis of material/product/production process deviation and OOS, using when required multiple data sources and data interpretation methods;
- Align and collaborate with GMD PM to define Lifecycle Management action plan, accountabilities and ensure LCM initiatives monitoring;
- Support Global Manufacturing PMs with the preparation of key deliverables for governing bodies updates on Lifecycle Management activities (e.g., business cases);
- Participate constructively or Coordinate Extended Teams and work packages development meetings when required (e.g., ETTs, Technical Maintenance, Operative Teams);
- Collaborate with Virtual Plant Managers and Procurement in defining commercial agreements technical contents;
- Participate to diligence activities in projects involving more disciplines, as needed.
**Experience Required**
- At least 5 years' experience in development / scale-up or technology transfer in international pharmaceutical environment.
**Education**
- Bachelor's or Master's Degree in scientific disciplines (CTF, Pharmacy, Biotechnology, etc.)
**Languages**
- Fluent English (both written and spoken)
**Technical Skills**
- Sound competences in pharmaceutical technologies as pMDI (preferred) / Sterile products/ DPI;
- Good Knowledge on Lean Six Sigma and Six Sigma methods;
- Good knowledge of pharmaceutical legislation and main international regulatory frameworks (cGMP, EMA guidelines, FDA and ICH).
**Soft Skills**
- Communication skills
- Decision mak
-
Global Process Validation Sme
3 mesi fa
Parma, Italia Chiesi Group A tempo pienoWho we are looking forPurposeThe figure will act as a Subject Matter Expert of Process Validation and technical maintenance activities within the Corporate Products Industrialization department and will interface with internal and external stakeholders as R&D, Operations and contract manufacturers/subcontractors.He/She will be responsible for coordinating of...
-
Global Process Validation SME
3 mesi fa
Parma, Italia Chiesi Group A tempo pienoWho we are looking for Purpose The figure will act as a Subject Matter Expert of Process Validation and technical maintenance activities within the Corporate Products Industrialization department and will interface with internal and external stakeholders as R&D, Operations and contract manufacturers/subcontractors. He/She will be responsible...
-
Global Process Validation Sme
3 mesi fa
Parma, Italia Chiesi Farmaceutici A tempo pieno**Date**:Aug 29, 2024**Department**:Corporate Products Industrialisation**Job Type**:Direct Employee**Team**:Industrial Operations & HSE**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...
-
QA Validation Specialist
1 settimana fa
Parma, Italia GSK A tempo pieno**Site Name**: Italy - Parma **Posted Date**: Dec 6 2024 We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work...
-
Parma, Italia Amaris Consulting A tempo pienoJob description CQV & Process Validation Specialist - Pharma Industry Cosa farai? Eseguire attività di Validation di equipment produttivi (CQV). Garantire il rispetto delle linee guida normative e degli standard GMP. Eseguire attività di validazione di processo produttivo per azienda farmacautiche. Sviluppare...
-
Senior Validation Specialist
3 settimane fa
Parma, Emilia-Romagna, Italia MAASI Enterprises Ltd A tempo pienoWe are seeking a highly skilled and experienced Senior Validation Specialist to join our team in the Life Sciences sector.The ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech industry, specifically in Computerised System Validation (CSV), validation protocols, and Validation Plan, IQ/OQ/PQ...
-
System Validation Professional
2 settimane fa
Parma, Emilia-Romagna, Italia Massimi Sistemi S.r.l. A tempo pienoComputerised System Validation Specialist Job in ParmaWe are currently recruiting for a Computerised System Validation specialist position at our internationally renowned client in the Life Sciences sector.The ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech industry, specifically in CSV...
-
Parma, Italia Maasi Enterprises Ltd A tempo pienoComputerised System Validation Specialist, prov. Parma (Italy) Pisa, Italy We are currently recruiting for our internationally renowned client in the Life Sciences sector, seeking three Computerised System Validation specialists. The ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech...
-
Parma, Italia Maasi Enterprises Ltd A tempo pienoComputerised System Validation Specialist, prov. Parma (Italy)Pisa, ItalyWe are currently recruiting for our internationally renowned client in the Life Sciences sector, seeking three Computerised System Validation specialists.The ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech industry,...
-
Parma, Italia Massimi Sistemi S.R.L. A tempo pienoComputerised System Validation Specialist, prov.Parma (Italy)We are currently recruiting for our internationally renowned client in the Life Sciences sector, seeking three Computerised System Validation specialists.The ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech industry, specifically...
-
Parma, Italia Massimi Sistemi S.R.L. A tempo pienoComputerised System Validation Specialist, prov. Parma (Italy) We are currently recruiting for our internationally renowned client in the Life Sciences sector, seeking three Computerised System Validation specialists. The ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech industry,...
-
Parma, Italia Massimi Sistemi S.r.l. A tempo pienoComputerised System Validation Specialist, prov. Parma (Italy) We are currently recruiting for our internationally renowned client in the Life Sciences sector, seeking three Computerised System Validation specialists. The ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech industry,...
-
Parma, Italia MAASI Enterprises Ltd A tempo pienoComputerised System Validation Specialist, prov. Parma (Italy) Pisa, Italy We are currently recruiting for our internationally renowned client in the Life Sciences sector, seeking three Computerised System Validation specialists. The ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech...
-
Parma, Italia Data Rover A tempo pienoComputerised System Validation Specialist, prov. Parma (Italy)Pisa, ItalyWe are currently recruiting for our internationally renowned client in the Life Sciences sector, seeking three Computerised System Validation specialists.The ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech industry,...
-
Parma, Italia Data Rover A tempo pienoComputerised System Validation Specialist, prov. Parma (Italy) Pisa, Italy We are currently recruiting for our internationally renowned client in the Life Sciences sector, seeking three Computerised System Validation specialists. The ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech...
-
Parma, Italia Data Rover A tempo pienoComputerised System Validation Specialist, prov. Parma (Italy) Pisa, Italy We are currently recruiting for our internationally renowned client in the Life Sciences sector, seeking three Computerised System Validation specialists. The ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech...
-
Parma, Italia Massimi Sistemi S.R.L. A tempo pienoComputerised System Validation Specialist, prov.Parma (Italy) We are currently recruiting for our internationally renowned client in the Life Sciences sector, seeking three Computerised System Validation specialists.The ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech industry, specifically...
-
Parma, Italia Maasi Enterprises Ltd A tempo pienoComputerised System Validation Specialist, prov.Parma (Italy) Pisa , Italy We are currently recruiting for our internationally renowned client in the Life Sciences sector, seeking three Computerised System Validation specialists.The ideal candidate will have at least two to three years of operational experience in the pharmaceutical and/or biotech industry,...
-
QA Validation Specialist
6 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
6 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...
