Quality Assurance Employee

ACS Dobfar S.p.A.; Tribiano; On-site; EUR 32,000 - 42,000; Full time

Job summary

ACS Dobfar S.p.A. is seeking a Quality Assurance Employee to assist in GMP quality events, document management, and QA documentation preparation. The role involves data entry, organizing change-related records, and supporting SOP development, training verification, and regulatory readiness.

The candidate should have basic GMP knowledge, familiarity with data integrity, and good attention to detail. Italian fluency and professional English are preferred, with entry-level experience in pharma

Qualifications

• Degree or Diploma in a chemical/pharmaceutical field.
• Experience in GMP environments is preferred but not required.
• Familiarity with GMP documentation and QA processes is beneficial.

Responsibilities

• Supports GMP quality events management (changes, complaints, deviations, CAPAs) via electronic document system.
• Collects and organizes supporting documentation for change requests, complaints, deviations, and CAPAs.
• Monitors GMP compliance activities and reports discrepancies to QA supervisors.
• Assists in preparing GMP documents including risk assessments and validation reports.
• Supports drafting and updating SOPs and other quality documents.
• Verifies training records and monitors qualification status.
• Verifies alarms/events in SCADA and reports issues to QA.

Skills

Attention to detail

Teamworking

Organizational skills

Willingness to learn GMP

Reliability and accountability

Education

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

Diploma from an Industrial Technical Institute with specialization in Chemistry

Tools

Microsoft Office tools

Electronic document management systems

SCADA systems

SAP or similar ERP systems

Job description

Role: Quality Assurance Employee

Reports to: QA Manager

Main Responsibilities:

• 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:

• 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:

• Attention to detail and accuracy
• Teamworking attitude
• Organizational skills
• Willingness to learn and develop GMP knowledge
• Reliability and accountability

IT Skills Required:

• 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:

• 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:

• Entry level or initial experience in the pharmaceutical sector.
• Internship or 0–2 years of experience in GMP environments (Quality Assurance, Production, QC or similar).