Pharma QA: Batch Record Review Specialist

Amaris Consulting | Part of Mantu; Latina; On-site; EUR 24,000 - 36,000; Full time

Benefits offered by this job

International community

Internal Academy training

CSR programs

Job summary

Amaris Consulting | Part of Mantu in Italy seeks a Pharmaceutical Quality Assurance professional to ensure GMP and regulatory alignment. You will review batch records, support audits, and drive CAPA while collaborating with production, R&D and supply chain to uphold quality across processes.

The role requires 1+ year in pharma QA, strong GMP knowledge, and fluency in Italian and English, with a Master’s degree in a related field. An international environment and training are offered.

Qualifications

• 1+ year experience in Quality Assurance in pharma.
• Solid knowledge of GMP guidelines and regulatory standards.
• Experience with Batch Record Review in sterility field.

Responsibilities

• Ensure GMP compliance and regulatory standards across products.
• Perform document review and approval (batch records, SOPs, quality manuals).
• Conduct deviation analysis and CAPA implementation/monitoring.
• Support audits/regulatory inspections with prepared documentation.
• Collaborate with production, R&D and supply chain to maintain quality.
• Perform risk assessments and contribute to continuous improvement.
• Provide training on quality procedures and regulatory updates.
• Prepare and present reports on quality indicators and progress.

Skills

Quality Assurance

GMP knowledge

Regulatory standards

Analytical skills

Team collaboration

Education

Master’s degree in Pharmacy / Biotechnology / Chemistry

Job description

Amaris Consulting | Part of Mantu in Italy seeks a Pharmaceutical Quality Assurance professional to ensure GMP and regulatory alignment. You will review batch records, support audits, and drive CAPA while collaborating with production, R&D and supply chain to uphold quality across processes.

The role requires 1+ year in pharma QA, strong GMP knowledge, and fluency in Italian and English, with a Master’s degree in a related field. An international environment and training are offered.