Senior QA Operations & Process Validation Specialist

Alfasigma; Alanno; In loco; EUR 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

Alfasigma is seeking a Senior Associate, QA Operations & Validation to ensure GMP-compliant quality operations and validation activities. You will manage process validation, documentation for product release, and collaboration with internal teams and external manufacturers.

The role emphasizes batch release support, deviation management, CAPA, and continuous improvement within a global healthcare environment, requiring a scientific degree and English fluency.

Competenze

• Degree in a scientific discipline such as Chemistry, Pharmaceutical Chemistry and Technology, Chemical Engineering, Biology or Pharmaceutical Biotechnology.
• Proven experience in Quality Assurance within pharmaceutical or life sciences environments.
• Strong understanding of GMP and QA Validation activities; knowledge of process validation and CAPA.
• Experience with quality documentation review and batch release processes; proficiency with TrackWise, SAP or Veeva.

Mansioni

• Support execution and oversight of Process Validation activities and ICH Q3D requirements.
• Collect, review, and maintain quality documentation for product release, including Batch Records.
• Ensure batch documentation is complete, accurate, and compliant with regulatory standards.
• Support batch release in line with GMP, quality procedures, and Quality Agreements with manufacturers.
• Collaborate to manage deviations, quality events, and product complaints with internal and external partners.
• Participate in investigations, root cause analysis, and CAPA; follow up on action effectiveness.

Conoscenze

Quality Assurance

GMP Knowledge

Process Validation

CAPA Management

Documentation Review

Batch Release

TrackWise

SAP

Veeva

Root Cause Analysis

English Fluent

Formazione

Scientific Degree

Strumenti

TrackWise

SAP

Veeva

Quality Systems

Descrizione del lavoro

Alfasigma is seeking a Senior Associate, QA Operations & Validation to ensure GMP-compliant quality operations and validation activities. You will manage process validation, documentation for product release, and collaboration with internal teams and external manufacturers.

The role emphasizes batch release support, deviation management, CAPA, and continuous improvement within a global healthcare environment, requiring a scientific degree and English fluency.