Role: Quality Assurance Employee

Non si lasci sfuggire questa possibilità: si candidi rapidamente se la sua esperienza e le sue competenze corrispondono a quanto descritto di seguito.
Reports to: QA Manager
Main Responsibilities:

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- Supports the management of GMP quality events, including changes, complaints, deviations, and CAPAs through the electronic document management system, ensuring correct data entry and document collection.

- Collects and organizes supporting documentation related to change requests, complaints, supplier complaints, deviations, and CAPAs under the supervision of the QA Manager or QA Specialist.

- Supports the monitoring of GMP compliance activities defined in approved documents, reporting potential discrepancies or delays to QA supervisors.

- Assists in the preparation and maintenance of GMP documentation, including Risk Assessments, cleaning validation reports, cross-contamination reports, and qualification protocols and reports for equipment, facilities, and environments.

- Supports the drafting, formatting, and updating of Standard Operating Procedures (SOPs) and other quality documents.

- Supports training compliance activities, verifying training records and monitoring personnel qualification status.

- Performs preliminary verification of alarms and events recorded in SCADA systems in production and warehouse areas and reports relevant issues to QA supervisors.

- Supports cleaning validation and cross-contamination prevention activities, ensuring documentation is properly collected and filed.

- Assists in the preparation and maintenance of GMP compliance documentation, including quality plans, tracking lists, and documentation under QA responsibility.

- Supports the preparation of Annual Product Quality Reviews (APQRs)



by collecting and organizing the required data and documentation.

- Monitors document expiration dates (SOPs, protocols, reports) and notifies responsible personnel to ensure timely revision.

- Ensures correct document management in accordance with document control procedures and supports the archiving process.

- Provides support during customer audits and regulatory inspections, preparing documentation and assisting QA personnel when required.

Technical / Regulatory Skills Required:

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- Basic knowledge of cGMP regulations

- Basic understanding of data integrity principles (ALCOA)

- Basic knowledge of pharmaceutical manufacturing processes

- Familiarity with GMP documentation systems

Soft Skills Required:

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- Attention to detail and accuracy

- Teamworking attitude

- Organizational skills

- Willingness to learn and develop GMP knowledge

- Reliability and accountability

IT Skills Required:

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- Basic knowledge of Microsoft Office tools (Word, Excel, PowerPoint)

- Familiarity with electronic document management systems (preferred)

- Basic knowledge of SCADA systems (preferred)

- Basic knowledge of SAP or similar ERP systems (preferred)

Language Skills Required:

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- Italian: Native or professional proficiency, written and spoken (C1)

- English: Professional proficiency, written and spoken (B2)

Education:

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- 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:

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- Entry level or initial experience in the pharmaceutical sector. xysqume

- Internship or 0–2 years of experience in GMP environments (Quality Assurance, Production, QC or similar).

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📌 Quality Assurance Employee (Tribiano)
🏢 ACS DOBFAR
📍 Tribiano