Quality Assurance Employee

7 ore fa

milano, lombardia, Italia ACS DOBFAR Tempo pieno

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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

Soft Skills Required

IT Skills Required

Language Skills Required

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

Employment type

Job function

Industries