Quality Assurance GMP Spain

Resourcing Life Science Ltd.; España; In loco; EUR 55.000 - 90.000; Tempo pieno

Descrizione del lavoro

Resourcing Life Science Ltd. is seeking a Quality Assurance professional to maintain GMP compliance across manufacturing and finished products, and to drive continuous improvement in QA processes.

You will review SOPs, investigate deviations and CAPAs, manage audits with customers and regulators, and prepare quality reports and agreements to support a strong quality culture throughout the organization. Additionally, you will mentor production teams on quality requirements and contribute to

Competenze

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

Mansioni

• 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.

Conoscenze

Quality Assurance

GMP compliance

Audit management

CAPA system

Root cause analysis

Regulatory knowledge

Formazione

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

Descrizione del lavoro

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