> Quality Management: Develop and maintain Quality Management System on eQMS (Qualio); manage Company Policies and SOPs with stakeholder reviews.> ISO Compliance: Implement strategic processes aligned with ISO 9001 standards and business needs.> Vendor/Client Management: Serve as primary contact for quality assessments, vendor categorization, risk profiling, and audit frequency.> Audit Program Development: Build audit programs and liaise with clients for scheduling… Show more > Quality Management: Develop and maintain Quality Management System on eQMS (Qualio); manage Company Policies and SOPs with stakeholder reviews.> ISO Compliance: Implement strategic processes aligned with ISO 9001 standards and business needs.> Vendor/Client Management: Serve as primary contact for quality assessments, vendor categorization, risk profiling, and audit frequency.> Audit Program Development: Build audit programs and liaise with clients for scheduling, maintaining strong relationships throughout the audit process.> Risk Management: Participate in risk management activities, including SOW reviews.KPI Communication: Established quality-driven KPIs and distributed monthly Quality & Compliance Reports with trend analysis.> Document Governance: Implemented a Document Governance matrix for GDP processes.> Business Process Mapping: Mapped and optimized the Vendor Onboarding Process in coordination with Procurement, Finance, and Legal.> Root Cause Analysis Framework: Developed NC, CAPA, and SCAR framework, facilitating cross-functional investigations and resolutions.> On-Site Client Audit: Led the company’s first on-site client audit, ensuring timely completion of corrective actions with client counterparts.> Cost Negotiation: Negotiated reduced costs for the eQMS platform, aligning user licenses with financial strategy for savings. Show less

> Quality Control: Supervise and coordinate all analytical QC work; approve product releases and validation activities.> Regulatory Compliance: Ensure adherence to FDA, MHRA, and BSI regulations for licensed drugs and medical devices.> Root Cause Analysis: Lead investigations of non-conformances, conduct risk assessments, and implement CAPA.> Product Development: Collaborate with R&D on new product feasibility, budget, and capacity planning.> KPI Reporting:… Show more > Quality Control: Supervise and coordinate all analytical QC work; approve product releases and validation activities.> Regulatory Compliance: Ensure adherence to FDA, MHRA, and BSI regulations for licensed drugs and medical devices.> Root Cause Analysis: Lead investigations of non-conformances, conduct risk assessments, and implement CAPA.> Product Development: Collaborate with R&D on new product feasibility, budget, and capacity planning.> KPI Reporting: Provide real-time KPI metrics to Senior Management.> Management Reviews: Participate in quarterly reviews per cGMP requirements.> Audit Management: Assist in internal and external audits; collaborate with clients to resolve issues promptly. Lead Auditor role internally and perform vendor site audits. ISO 13485 Auditor Certified. > Change Management: Lead and review change management tasks on eQMS (Windchill); act as Quality SME for CAPA.> Equipment Qualification: Coordinate qualifications and validations of lab instruments to prevent downtime.> ISO Recertification: Manage labs recertification processes for ISO 9001 and ISO 13485.> Cost Reduction: Streamline workflows to reduce day-to-day costs with Lean initiatives. > Process Improvement: Work with customers to reduce reliance on third-party analysis, enhancing profit margins and reducing release times.> Key contributor in expansion of laboratory operations. Involved overseeing facility management, coordinating utilities, and managing the build of new lab spaces. Responsibilities - obtaining equipment quotes, facilitating purchases, and ensuring the proper installation and qualification of all lab equipment. Show less

> Product Development/Project Management: Lead technical aspects of New Product Initiations (NPI) and product introductions in various markets.> Design Control Compliance: Ensure adherence to all Design Control requirements.> Technical Transfer: Facilitate hands-on technical transfer to manufacturing, completing the Technical Transfer Checklist prior to transfer date; create testing methods and specifications in collaboration with R&D, manufacturing, and Regulatory… Show more > Product Development/Project Management: Lead technical aspects of New Product Initiations (NPI) and product introductions in various markets.> Design Control Compliance: Ensure adherence to all Design Control requirements.> Technical Transfer: Facilitate hands-on technical transfer to manufacturing, completing the Technical Transfer Checklist prior to transfer date; create testing methods and specifications in collaboration with R&D, manufacturing, and Regulatory Affairs.> Project Prioritization: Manage multiple projects across different sites and time zones, adapting work hours as needed.> Collaboration: Seamlessly integrated into the Solutions Engineering team, taking over multiple in-flight projects while meeting deliverable deadlines.> Product Development/R&D: Successfully transferred technical designs for four new product families to manufacturing, ready for sale in Mar, Jul, Aug, and Oct 2018.> ISO Expertise: Subject Matter Expert (SME) for ISO 15747 concerning Plastic Containers for Intravenous Injections.> NPI SME: Act as SME for Solutions Engineering in New Product Introductions (NPI).> Continuous Improvement: Developed new procedures to enhance structure and robustness for NPI processes.> Client Engagement: Foster strong relationships with clients by addressing their needs, providing solutions, and ensuring a high level of service and satisfaction. Show less