Key Responsibilities

Executes analyses on excipients, raw materials, finished products, and packaging per internal SOPs and applicable pharmacopeias.
Conducts stability studies, process and method validations, and activities related to tech transfer of pharmaceutical products.
Performs instrument qualification and re-qualification (IQ/OQ/PQ) according to internal procedures.
Records analytical data in compliance with ALCOA+ principles and data integrity requirements.
Reviews GMP documentation, batch records, analytical reports, and certificates for completeness and compliance.
Collaborates with QA, Production, and R&D; supports method transfers, troubleshooting, and safe lab/5S practices.
Participates in audits and inspections by providing data and responses; contributes to CAPA, deviations, change control, and SOP updates.
Tracks KPIs: on-time completion and right-first-time rates, data integrity compliance, audit outcomes, documentation quality, and continuous improvement impact.

Essential Requirements

Degree in Chemistry
Solid technical-scientific knowledge of pharmaceutical/chemical QC or equivalent analysis
Previous experience working in a laboratory environment in the pharmaceutical industry
Experience in GMP environment
Fluent in Italian and English

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