18 oct
|
Resourcing Life Science
|
España
18 oct
Resourcing Life Science
España
Your responsibilitiesMaintain 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 profileA 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 / biotechPractical knowledge of GMP requirements, audit processes, deviation management and CAPA system
📌 Quality Assurance GMP Spain (España)
🏢 Resourcing Life Science
📍 España