Quality Assurance Specialist QA Validation

1 giorno fa

Milano, Lombardia, Italia Recordati A tempo pieno
Job Purpose

Lo Specialista Assicurazione Qualità garantisce che i processi produttivi, analitici e documentali siano conformi alle normative vigenti (GMP, GDP, normative AIFA) e agli standard di qualità aziendali.

The Quality Assurance Specialist ensures that manufacturing, analytical and documentation processes comply with applicable regulations (GMP, GDP, AIFA) and internal quality standards.

Key Responsibilities
  • Garantire la conformità dei processi alle normative GMP e alle procedure interne
  • Effettuare indagini (deviazioni e/o reclami) e redigere i relativi report
  • Revisionare Master Batch Record
  • Revisionare anagrafiche e ricette (incluso il flusso degli Art Work)
  • Revisionare Audit Trail di sistema e gestire aspetti di Data Integrity
  • Scrittura protocolli/report di convalida

  • Ensure compliance of processes with GMP regulations and internal procedures
  • Investigation and related reporting (complaints and/or deviation)
  • Review and manage the flows of the Master Batch Records
  • Review of Master Data and Recipe (including Art Work flow)
  • Review Audit Trail and Data Integrity management
  • Drafting of validation protocol/report
Required Education

Laurea in discipline scientifiche (Chimica, CTF, Farmacia, Biologia o affini)

Degree in a scientific discipline (Chemistry, Pharmaceutical Sciences, Biology or equivalent)

Required Skills and Experience

Esperienza di almeno 1 anno in Assicurazione Qualità in ambito chimico-farmaceutico

At least 1 year of experience in Quality Assurance within the pharmaceutical or chemical industry

Technical Competencies

Conoscenza delle GMP e delle normative di settore

Knowledge of GMP and applicable regulations

Required Languages

Buona conoscenza della lingua inglese

Good knowledge of the English language

Travel required in %

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