Quality Assurance Employee

13 ore fa

milano, lombardia, Italia ACS Dobfar S.p.A. Tempo pieno

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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).

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).

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Quality Assurance Employee

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