ACS DOBFAR S.p.A., multinazionale italiana, leader nella produzione di API e Prodotti Finiti, è alla ricerca di un Quality Assurance Validation Employee con esperienza da inserire presso lo stabilimento produttivo di Tribiano (MI).
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Role: Quality Assurance Validation Employee
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Reports to: QA Manager Main Responsibilities: Prepares and maintains GMP documentation, including validation protocol and reports of the activities in charge, including Risk Assessments, process validation, cleaning validation and cross-contamination. Coordinates activities related to process validation, cleaning validation and cross-contamination, ensuring compliance with approved protocols and procedures.
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Collects, reviews, and organizes supporting documentation related to change controls related to process validation, cleaning validation and cross-contamination.
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Support the QA investigation in GMP quality events including changes, complaints, deviations, and CAPAs with impact on process validation, cleaning validation and cross-contamination
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Monitors the progress of GMP compliance activities defined in approved documents and quality systems, highlighting potential delays or discrepancies to the QA Manager.
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Prepares and maintains GMP compliance documentation, including quality plans, compliance lists, and documentation under QA responsibility relevant to process validation, cleaning validation and cross-contamination.
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Supports regulatory affairs department.
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Supports self-inspection, customer audits and regulatory inspections, preparing documentation and assisting QA management during inspections.
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Technical / Regulatory Skills Required: Good knowledge of cGMP regulations and pharmaceutical quality systems
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Basic knowledge of data integrity principles (ALCOA / ALCOA+)
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Understanding of pharmaceutical manufacturing processes and GMP documentation systems
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Familiarity with quality management systems (QMS) including validation, risk assessment, deviations, CAPA, change control, and complaints management Soft Skills Required: Strong attention to detail and accuracy
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Teamworking and cross-functional collaboration
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Problem-solving attitude
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Analytical and critical thinking skills
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Good organizational and time-management skills IT Skills Required: Good knowledge of Microsoft Office tools (Word, Excel, PowerPoint)
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Familiarity with electronic document management systems (EDMS) and quality management systems
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Knowledge of SCADA systems (preferred)
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Basic knowledge of SAP or similar ERP systems (preferred) Language Skills Required: Italian: Native or professional proficiency, written and spoken (C1)
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English: Professional proficiency, written and spoken (B2) Education: Degree in Chemistry, Chemistry and Pharmaceutical Technology (CTF), Pharmacy, Biology or related scientific disciplines (preferred) or
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Diploma from an Industrial Technical Institute with specialization in Chemistry Previous Experience: Experience in a QA role or in another GMP department within the pharmaceutical sector preferably with experience in validation activities 1–3 years of experience in pharmaceutical quality systems (preferred)