Process Validation SME

1 settimana fa

Parma, Italia Chiesi A tempo pieno
About 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, 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 forPurposeThe person will be the Subject Matter Expert of Process Validation and technical maintenance activities within industrialization and product technology transfer and will interface with internal and external stakeholders as R&D, Operations and contract manufacturers / subcontractors. The figure will be also responsible for coordinating maintenance activities for in-market products.

Main Responsibilities•

Act as the key reference person for Manufacturing functions (including 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 (Parma, Blois, Santana, Virtual); •

Align and collaborate with Global Manufacturing PM to define LCM activities action plan, accountabilities and ensure LCM initiatives monitoring; •

Support Global Manufacturing PM with the preparation of key deliverables for governing bodies (TMPT / GMD LT) updates on LCM 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; •

Experience with sterile products is considered as an essential requirement.EducationScientific Bachelor's or Master's DegreeLanguagesFluent English (both written and spoken)Technical Skills•

Sound competences in pharmaceutical technologies as sterile DP (Sterile liquid and sterile liophilized products); •

Good knowledge of laboratory analytical technologies and their applications in processes (PAT); •

Good knowledge of pharmaceutical legislation and main international regulatory frameworks (cGMP, EMA guidelines, FDA and ICH).Soft SkillsAdaptability and flexibility Communication skills Decision making Leadership and social influence Problem solving Proactiveness 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.

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