Since 1997 Monteresearch has been at the forefront of pharmaceutical R&D;, designing and optimising advanced drug-delivery technologies that go “Beyond the Standard of Care.” Today we operate a purpose-built 1,800 m² GMP-qualified site near Milan and sit within EMS (NC Group) - Brazil’s largest pharmaceutical company - giving our teams the agility of a specialised lab and the resources of a global network. Our mission is to transform bold scientific concepts into market-ready therapies for unmet medical needs, with a focus on repositioning small molecules, oral peptides and oligonucleotides in gastroenterology, dermatology and ophthalmology. End-to-end in-house capabilities span formulation and analytical development, IMP manufacturing, clinical supply, regulatory CMC, and pivotal trial management, allowing scientists to see their ideas progress from benchtop to first-in-human studies under one roof. Monteresearch srl is a pharmaceutical company authorized by AIFA for testing and batch certification of Human Medicinal Products (imported) and manufacturing of IMPs (not sterile). Joining Monteresearch means collaborating in an environment that values scientific rigour, innovation and a strong sense of belonging. You will work alongside multidisciplinary experts who share a commitment to reliability, quality and patient-centric solutions, backed by the stability and growth prospects of an international group. If you are driven to shape the future of drug delivery and make a tangible impact on global health,



we invite you to explore the opportunity below. We are looking for a **Quality Assurance Specialist.** **Site**:Milan Area, Italy **The position foresees**: - Audit on API and Excipient Manufacturing sites located in Europe
- Deviation and CAPA Management
- Equipment Qualification Management (protocol verification and approval, report evaluation and approval, qualification and maintenance plan management)
- Support in Quality Controlled documents (SOPs and Working Instructions) management in the company Documentation System
- Support in Change Control management
- Support in Approval and monitoring of Qualified Suppliers
- Support of Training assignments
- Support during Customer/Authority Audit **Requirements**: - Bachelor’s or Master’s degree in a scientific field (e.g. Pharmacy, Biology, Bio Eng)
- 2+ years of experience in Quality Assurance Field
- Experience and knowledge of cGMP Guidelines
- Computer skills (e.g. Excel, Word, Power Point)
- Knowledge of sterile/biological Medicinal Product release is a plus **Skills**: - Fluent English both spoken and written
- Self-directed and motivated
- Precision and focused on details
- Collaborative and good team player
- Strong organizational skills and communication skills Contratto di lavoro: Tempo pieno, Tempo indeterminato Retribuzione: €27.000,00 - €35.000,00 all'anno Agevolazioni: - Buoni pasto Disponibilità: - Dal lunedì al venerdì

📌 Quality Assurance Specialist (Bollate)
🏢 MONTERESEARCH
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