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Resourcing Life Science
h3Your responsibilities /h3ulliMaintain compliance with GMP requirements and applicable quality regulations across manufacturing processes and finished products. /liliReview, develop and update SOPs, work instructions and quality documentation, ensuring these are followed consistently in daily operations. /liliAssess production and batch documentation for accuracy and compliance, taking appropriate action when products do not meet release requirements. /liliInvestigate quality incidents and deviations, work with relevant departments to identify root causes, and ensure corrective and preventive actions are implemented effectively. /liliManage customer complaints, oversee investigations and coordinate the implementation of appropriate CAPAs. /liliPlan and perform internal audits, document findings and ensure agreed improvements are completed. /liliCoordinate external audits and inspections by customers and regulatory authorities, including preparation, responses and follow-up activities. /liliCompile annual product quality reviews,
assess quality system performance and prepare required reports and management information. /liliSupport quality-related discussions with internal teams and external partners, including the preparation and review of quality agreements. /liliAdvise production teams on quality requirements, promote GMP awareness and encourage a strong quality culture throughout the organization. /liliIdentify opportunities to improve Quality Assurance processes, monitor relevant KPIs and contribute to departmental performance reporting. /li /ulh3Your profile /h3ulliA bachelor’s or master’s degree in a relevant scientific or technical discipline. /liliAt least five years of Quality Assurance experience / GMP-regulated environment in pharma / biotech /liliPractical knowledge of GMP requirements, audit processes, deviation management and CAPA system /li /ul #J-18808-Ljbffr
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