Quality Assurance Employee

ACS DOBFAR; Tribiano; In loco; EUR 30.000 - 40.000; Tempo pieno

Descrizione del lavoro

A pharmaceutical manufacturing company based in Tribiano, Italy, is seeking a Quality Assurance Employee. This entry-level position involves managing documentation for changes, complaints, and GMP compliance activities. Candidates should possess a Diploma in Chemistry and have 1-2 years of experience in a similar role. Proficiency in Italian and English, alongside various IT skills, is required. The role offers a full-time employment contract within a supportive team environment.

Competenze

• Minimum 1-2 years experience in a similar role within the pharmaceutical sector.
• Degree in Chemistry or related fields preferred.

Mansioni

• Manage changes, complaints, deviations, and CAPAs through documentation.
• Draft and maintain GMP documentation including SOPs.
• Coordinate cleaning and cross-contamination activities.

Conoscenze

Attention to detail and accuracy

Teamworking attitude

Problem-solving orientation

Good analytical skills

Basic knowledge of cGMP regulations

Formazione

Diploma of Industrial Technical Institute in Chemistry

Strumenti

Microsoft Office

Document management systems

SCADA systems

SAP system

Descrizione del lavoro

Role

Quality Assurance Employee

Reports to

QA Manager

Main responsibilities

• Manages changes, complaints, deviations, and CAPAs through the electronic document management system.
• Collects and organizes supporting documentation for change requests, complaints, supplier complaints, deviations, and CAPAs.
• Monitors the progress of all GMP compliance activities defined in approved documents, reporting discrepancies to Supervisors.
• Drafts and maintains GMP documentation such as Risk Assessments, cleaning and cross-contamination reports, qualification protocols and reports for equipment, plants, and environments.
• Drafts and updates general and site-specific Standard Operating Procedures (SOPs).
• Verifies staff participation and supervises the qualification status of personnel.
• Verifies alarms on SCADA system in production and warehouse areas, ensuring they are handled appropriately.
• Coordinates cleaning and cross-contamination activities in accordance with approved protocols and SOPs.
• Prepares and updates GMP compliance lists, plans, and documentation under QA responsibility.
• Drafts the Annual Product Quality Reviews (APQRs) and sends them to clients.
• Monitors document expiration dates (SOPs, protocols, etc.) and ensures timely revisions.
• Ensures compliance with documentation control procedures throughout the document lifecycle.
• Manage the Customer audit and assist management in regulatory inspection

Technical/Regulatory Skills Required

• Basic knowledge of cGMP and data integrity regulations (ALCOA principles).
• Basic knowledge of main manufacturing processes.

Soft Skills Required

• Attention to detail and accuracy
• Teamworking attitude
• Problem-solving orientation
• Good analytical skills

IT Skills Required

• Competency with Microsoft Office tools (Word, Excel, PowerPoint)
• Good knowledge of document and management systems (preferred)
• Good knowledge of SCADA systems (preferred)
• Basic knowledge of SAP system

Language Skills Required

• Italian: Native or professional proficiency, written and spoken (C1).
• English: Professional proficiency, written and spoken (B2)

Education

• Diploma of Industrial Technical Institute with specialization in Chemistry, or Degree in Chemistry or Chemistry and Pharmaceutical Technology (preferred)

Previous experience in the role or similar position within the sector

• Minimum 1-2 years experience in a similar role within the pharmaceutical sector.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Production

Industries

• Pharmaceutical Manufacturing