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
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.
- Collects, reviews, and organizes supporting documentation related to change controls related to process validation, cleaning validation and cross-contamination.
- Support the QA investigation in GMP quality events including changes, complaints, deviations, and CAPAs with impact on process validation, cleaning validation and cross-contamination
- Monitors the progress of GMP compliance activities defined in approved documents and quality systems, highlighting potential delays or discrepancies to the QA Manager.
- 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.
- Supports regulatory affairs department.
- Supports self-inspection, customer audits and regulatory inspections, preparing documentation and assisting QA management during inspections.
Technical / Regulatory Skills Required:
- Good knowledge of cGMP regulations and pharmaceutical quality systems
- Basic knowledge of data integrity principles (ALCOA / ALCOA+)
- Understanding of pharmaceutical manufacturing processes and GMP documentation systems
- 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
- Teamworking and cross-functional collaboration
- Problem-solving attitude
- Analytical and critical thinking skills
- Good organizational and time-management skills
IT Skills Required:
- Good knowledge of Microsoft Office tools (Word, Excel, PowerPoint)
- Familiarity with electronic document management systems (EDMS) and quality management systems
- Knowledge xdwybme of SCADA systems (preferred)
- Basic knowledge of SAP or similar ERP systems (preferred)
Language Skills Required:
- Italian: Native or professional proficiency, written and spoken (C1)
- English: Professional proficiency, written and spoken (B2)
Education:
- Degree in Chemistry, Chemistry and Pharmaceutical Technology (CTF), Pharmacy, Biology or related scientific disciplines (preferred) or
- 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)