Quality Assurance GMP Italy

Resourcing Life Science Ltd.; Italia; On-site; EUR 65,000 - 95,000; Full time

Job summary

Resourcing Life Science Ltd. seeks a Quality Assurance professional to uphold GMP compliance across manufacturing and finished products, review SOPs, and ensure documentation integrity.

The role leads internal audits, coordinates external inspections, drives CAPA actions, and promotes a strong quality culture throughout the organization.

Qualifications

• Bachelor's or master's degree in a relevant scientific or technical field.
• Minimum five years' QA experience in GMP-regulated pharma/biotech.
• Practical knowledge of GMP, audit processes, deviation management and CAPA.

Responsibilities

• Maintain GMP compliance across manufacturing processes and finished products.
• Review, develop and update SOPs, work instructions and quality documentation.
• Assess production and batch documentation for accuracy and compliance.
• Investigate quality incidents and deviations; identify root causes and implement CAPAs.
• Manage customer complaints; oversee investigations and CAPA implementation.
• Plan and perform internal audits; document findings and drive improvements.
• Coordinate external audits and inspections by customers and regulators.
• Compile annual product quality reviews and assess quality system performance.
• Support quality discussions with internal teams and external partners.
• Prepare and review quality agreements; promote GMP awareness.
• Advise production teams on quality requirements; foster quality culture.
• Identify opportunities to improve QA processes and monitor KPIs.

Skills

GMP knowledge

Quality mindset

Cross-functional collaboration

Education

Bachelor's or Master's in a relevant scientific/technical discipline

Tools

CAPA system

Job description

Your responsibilities

• Maintain compliance with GMP requirements and applicable quality regulations across manufacturing processes and finished products.
• Review, develop and update SOPs, work instructions and quality documentation, ensuring these are followed consistently in daily operations.
• Assess production and batch documentation for accuracy and compliance, taking appropriate action when products do not meet release requirements.
• Investigate quality incidents and deviations, work with relevant departments to identify root causes, and ensure corrective and preventive actions are implemented effectively.
• Manage customer complaints, oversee investigations and coordinate the implementation of appropriate CAPAs.
• Plan and perform internal audits, document findings and ensure agreed improvements are completed.
• Coordinate external audits and inspections by customers and regulatory authorities, including preparation, responses and follow-up activities.
• Compile annual product quality reviews, assess quality system performance and prepare required reports and management information.
• Support quality-related discussions with internal teams and external partners, including the preparation and review of quality agreements.
• Advise production teams on quality requirements, promote GMP awareness and encourage a strong quality culture throughout the organization.
• Identify opportunities to improve Quality Assurance processes, monitor relevant KPIs and contribute to departmental performance reporting.

Your profile

• A bachelor’s or master’s degree in a relevant scientific or technical discipline.
• At least five years of Quality Assurance experience / GMP-regulated environment in pharma / biotech
• Practical knowledge of GMP requirements, audit processes, deviation management and CAPA system