Responsible Person

Overall PurposeAs the Responsible Person you will ensure all wholesale, storage, and distribution activities within Sun Pharma BV comply with EU GDP legislation (2013/C 343/01), EU Directives (2001/83/EC, 2011/62/EU), Dutch Medicines Act, and Opium Act. Act as designated RP on the company’s Wholesaler Distributor Authorization (WDA).Key ResponsibilitiesEnsure implementation and maintenance of the GDP Quality Management System (QMS) including SOPs, KPIs, CAPAs, and training.Oversee storage and transport conditions, ensuring compliance and quality risk management.Maintain WDA license and submit annual API-registration/importation updates to authorities.Monitor GDP operations, ensure traceability, documentation, and record accuracy.Train and qualify supply chain personnel on GDP/GMP.Support QPs in product recalls and manage GDP-related customer complaints.Approve and audit suppliers, customers, and service providers for GDP/GxP compliance.Oversee outsourced activities, quality contracts, and performance monitoring.Conduct and/or participate in self-inspections; ensure CAPAs are closed on time.Decide on disposition of returned, rejected, recalled, or counterfeit medicines with QP.Collaborate with authorities in cases of falsification or GDP-critical incidents.AuthoritiesStop non-compliant operations.Approve/reject GDP suppliers, distributors, contracts, and documents.Represent the company with national/international authorities.Inform MAH and authorities of falsified or non-compliant medicines.KPIs≥95% GDP compliance rate.≥80% CAPAs closed on time.≥90% deviations closed within 30 days.100% on-time self-inspections & document reviews.≥95% shipments meet transport condition requirements.No major/critical findings during inspections.RequirementsEducation:Bachelor’s degree (mandatory); MSc preferred.Experience:5+ years in pharmaceutical quality management.Eligible and trained as Responsible Person under EU GDP.Strong knowledge of EU GDP/QMS operations.Experience in GDP auditing, QA for narcotics, and acting as certifying RP.Skills & CompetenciesStrong decision-making in critical quality incidents.Excellent collaboration and communication with senior management, supply chain, QA, regulators, and customers.Independent, proactive, results-oriented, flexible, and resilient under pressure.Availability outside working hours for critical events.