QA Validation Employee

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).

Role: Quality Assurance Validation Employee

Reports to: QA Manager

Main Responsibilities:

1. 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.
2. Coordinates activities related to process validation, cleaning validation and cross-contamination, ensuring compliance with approved protocols and procedures.
3. Collects, reviews, and organizes supporting documentation related to change controls related to process validation, cleaning validation and cross-contamination.
4. Support the QA investigation in GMP quality events including changes, complaints, deviations, and CAPAs with impact on process validation, cleaning validation and cross-contamination
5. Monitors the progress of GMP compliance activities defined in approved documents and quality systems, highlighting potential delays or discrepancies to the QA Manager.
6. 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.
7. Supports regulatory affairs department.
8. Supports self-inspection, customer audits and regulatory inspections, preparing documentation and assisting QA management during inspections.

Technical / Regulatory Skills Required:

1. Good knowledge of cGMP regulations and pharmaceutical quality systems
2. Basic knowledge of data integrity principles (ALCOA / ALCOA+)
3. Understanding of pharmaceutical manufacturing processes and GMP documentation systems
4. Familiarity with quality management systems (QMS) including validation, risk assessment, deviations, CAPA, change control, and complaints management

Soft Skills Required:

1. Strong attention to detail and accuracy
2. Teamworking and cross-functional collaboration
3. Problem-solving attitude
4. Analytical and critical thinking skills
5. Good organizational and time-management skills

IT Skills Required:

1. Good knowledge of Microsoft Office tools (Word, Excel, PowerPoint)
2. Familiarity with electronic document management systems (EDMS) and quality management systems
3. Knowledge of SCADA systems (preferred)
4. Basic knowledge of SAP or similar ERP systems (preferred)

Language Skills Required:

1. Italian: Native or professional proficiency, written and spoken (C1)
2. English: Professional proficiency, written and spoken (B2)

Education:

1. Degree in Chemistry, Chemistry and Pharmaceutical Technology (CTF), Pharmacy, Biology or related scientific disciplines (preferred) or
2. 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)