Amersfoort, Utrecht, Netherlands
In the highly regulated and competitive pharmaceutical sector, managing compliance and operational challenges on your own can lead to unnecessary risks and missed opportunities. Engaging an experienced consultant is a strategic decision that safeguards your business, optimizes performance, and helps you maintain a strong competitive advantage. By engaging my services as your freelance pharmaceutical industry expert, you gain a trusted partner dedicated to enhancing your organization’s compliance, operational efficiency, and product quality. My support ensures strict adherence to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards, while proactively addressing and resolving compliance risks-protecting your business from regulatory pitfalls and safeguarding patient safety. What you achieve by hiring me: • Peace of mind: I am dedicated to maintaining your operations in accordance with all applicable compliance standards, and I take prompt, proactive steps to address any issues through corrective and preventive actions. • Operational excellence: With my expertise, your processes are streamlined, quality systems are optimized, and productivity is enhanced. • Risk reduction: I implement robust risk management and validation strategies, minimizing the likelihood of compliance breaches, product recalls, or patient safety concerns. • Regulatory confidence: My oversight ensures your company is always audit-ready, aligned with industry best practices, and prepared for any regulatory review. • Patient safety: Every aspect of my work is focused on ensuring that your products are safe, effective, and compliant-protecting the well-being of patients who rely on your medicines. By entrusting your compliance and quality management needs to me, you gain a competitive advantage-ensuring your products are safe for patients, your processes are efficient, and your company is fully prepared for any regulatory challenge. I'd welcome the opportunity to discuss how I can support your organization in achieving its compliance and quality objectives. To explore how my expertise can benefit your specific needs, feel free to contact me today to schedule a consultation. You can also review my background and experience by accessing my CV here: https://gregory-sivo.systeme.io/6d1ae762 Let's take the next step together toward operational excellence and regulatory confidence.
Subject matter expert for Good Distribution Practice (GDP) compliance across daily distribution operations, ensuring activities consistently meet EU GDP guidelines, regulatory requirements and internal quality standards. Key responsibilities: • Owning the end to end complaints management process, from intake and triage through root cause investigation, CAPA definition and closure, ensuring timely and well documented resolution. • Leading root cause analysis on quality complaints and deviations, identifying systemic issues and driving corrective and preventive actions that reduce recurrence. • Driving optimisation of daily quality activities, streamlining workflows, removing non value adding steps and improving turnaround times without compromising compliance. • Analysing complaint, deviation and KPI data to surface trends, produce management reporting and recommend risk based priorities to leadership. • Partnering with operations, warehouse and customer facing teams to translate quality data into practical process improvements. • Providing expert quality guidance and decision support, acting as the escalation point for GDP and complaint related queries. • Maintaining and continuously improving SOPs, work instructions and quality documentation in line with best practice and evolving regulatory expectations. • Supporting audits and regulatory inspections, including preparation, evidence gathering and follow up on findings. • Championing a culture of continuous improvement and quality awareness, embedding GDP standards into everyday ways of working.
Key Achievements: o Successfully led multiple GMP-compliant clinical production projects from Phase 1 through Phase 3, ensuring timely delivery of high-quality clinical trial materials through effective coordination of multidisciplinary teams and strict regulatory adherence. o Optimized the supplier qualification process, resulting in enhanced transparency, improved execution, and strengthened operational excellence within the supply chain. Core Responsibilities: o Ensure full compliance with GMP regulations regarding raw materials used in commercial manufacturing processes, consistently maintaining the highest quality standards. o Serve as Subject Matter Expert (SME) for internal stakeholders and external partners during technical transfers, facilitating seamless knowledge transfer and process integration. o Collaborate closely with project teams on the introduction of new raw materials, ensuring regulatory compliance and quality standards are met. o Regularly review and update Standard Operating Procedures (SOPs) to align with evolving regulatory requirements and internal quality policies. o Stay current with industry compliance guidelines and leverage this expertise to support ongoing quality initiatives. o Thoroughly evaluate and approve test protocols and material testing to safeguard product integrity and regulatory compliance. o Oversee final quality control for change management within site operations, including evaluation and documentation of changes from Production, Science & Technologies, and Supply Chain. o Actively participate in project and change control meetings to discuss quality requirements, identify risks, and proactively address compliance issues. o Collaborate closely with Quality Management to streamline decision-making and foster a culture of quality and continuous improvement.
Main responsibilities o Maintaining the QMS system o Act as Superuser for change control o Act as a Superuser for SAP data o Facilitating New Product Introduction Process o Facilitating Product Transfer Process o Facilitating Product Pruning Process o Safeguards Keeping files up to date o Ensuring the implementation of changes in product packaging and inserts o Initiation and completion of Corrective and preventive measures o Facilitating process optimization o Guarantee compliance storage at an external warehouse o Reporting known KPIs Education o Implementation of general Change control (Trackwise) training for new employees GMP related o Preparing and managing product-specific documentation for batch release o Guarantee implementation of new test methods for EU retest o Enter data for stability testing o Drafting and managing a Quality Agreement between Sandoz and Novartis o Drafting and managing a Quality Agreement between Sandoz and third parties o Facilitate Vendor/ Supplier qualification o Management of Vendor / Suppliers o Initiating and managing SOPs and GOPs o Initiating and managing work instructions Projects o Act as a Change control board member o Setting up and managing ICH / GMP projects such as ICH Q3D Elementary impurities Audit related o Assisting with customer audits o Assisting with Self-Inspections o Assisting with authorities audits o Taken as a Superuser appearance for SME o Acting as backoffice for audits Other activities o Safeguarding the destruction of opiate drugs o Conduct annual inventory at an external warehouse
A comprehensive assessment was conducted to evaluate the operational and clinical impact of Automatic Tablet Dispensing and Packaging Systems (ATDPS) within the healthcare ecosystem. The analysis focused on identifying key value drivers, operational efficiencies, and potential operational challenges associated with the deployment of ATDPS technology. The engagement culminated in the delivery of a strategic recommendation report, outlining actionable insights and implementation pathways to optimize system integration, enhance medication safety, and drive scalable improvements across healthcare operations.
Led a comprehensive partnership assessment aimed at evaluating the dynamics of collaboration among colleagues. This initiative focused on identifying strengths, addressing areas for improvement, and fostering a more cohesive and productive working environment to drive overall team performance