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