Quality System Analyst
3 settimane fa
We are looking for a Quality System Analyst to join a Pharmaceutical Company located in Pisa.
The selected candidate will be part of the Quality System & Compliance department and will play a key role in ensuring that all activities related to the AVI (Automated Visual Inspection Machine) project are executed in full compliance with internal procedures, GMP requirements and applicable regulatory guidelines.
Key Responsibilities
•Act as the primary Quality representative within the AVI project team, ensuring quality and compliance requirements are embedded in all project phases (design, installation, qualification, validation and routine use).
•Participate in the definition and review of URS, FAT/SAT, IQ/OQ/PQ protocols and reports for the new AVI machine.
•Support risk assessments (e.g. FMEA, risk analysis) and ensure that mitigation actions are identified, implemented and adequately documented.
•Ensure that project deliverables meet GMP, data integrity and regulatory expectations.
•Collaborate closely with Engineering, Production, Validation and IT in a cross-functional environment.
Within the Quality System & Compliance group:
•Support and maintain the site Change Control process, ensuring timely and compliant evaluation, approval, implementation and closure of change controls.
•Contribute to the Quality Validation activities (e.g. validation/qualification of equipment, utilities, computerized systems, processes, cleaning), by reviewing and/or approving validation documentation.
•Support the creation, revision and lifecycle management of GxP documentation (SOPs, work instructions, forms, validation protocols/reports, technical documentation).
•Support investigations, CAPA and continuous improvement initiatives related to the AVI system and other quality system processes.
Requirements
•University degree in Pharmacy, Chemistry, Biotechnology or related scientific/technical discipline.
•Previous experience (typically 1–3 years) in a pharmaceutical or biotech manufacturing environment, preferably in Quality Assurance / Quality Systems / Validation.
•Experience with inspection systems (manual or automated) and/or equipment/CSV
We offer an initial one-year contract, CCNL for the chemical and pharmaceutical industry.
Esperienze lavorative:
Quality Compliance Specialist - 18 mesi
Titolo di studio:
Laurea Magistrale - Chimico / Biologico / Ambientale
Lingue conosciute:
Inglese: Comprensione Ottimo
Competenze:
Chimica - Validazione Processi Farmaceutici, livello Buono
Altro - Documentazione Tecnica, livello Buono
Altro - Documentazione Conforme a Gmp
Information Technology Altro - Software Quality Assurance, livello Buono
Information Technology Altro - Trackwise, livello Buono
Disponibilità oraria: Full Time
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