Quality Assurance Employee
ACS DOBFAR S.p.
A., multinazionale italiana leader nella produzione di API e Prodotti Finiti, è alla ricerca di un Quality Assurance Employee da inserire nel dipartimento ufficio tecnico, con sede principale nel sito produttivo di Tribiano (MI). 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).
A., multinazionale italiana leader nella produzione di API e Prodotti Finiti, è alla ricerca di un Quality Assurance Employee da inserire nel dipartimento ufficio tecnico, con sede principale nel sito produttivo di Tribiano (MI). 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).