Amsterdam, North Holland, Netherlands
= Voor mijn Nederlandstalige profiel, klik rechtsboven = Dear visitor, Thank you for visiting my LinkedIn profile. Following summary describes a brief outline of my professional motives, abilities and perspectives. I have an engineering background, with a Bachelor of Science degree in Environmental Engineering and a Master of Science degree in Ecotoxicology. With 15+ years of work experience at both national and international operating organizations like TNO, Rijkswaterstaat, Waternet, Waterproef, Atrium Innovations, Mutifill, Crown Bioscience, and Prothya Biosolutions, I excel in quality development, project management and process optimization. As a professional, I am a venturous person who always strives for a results-oriented interpretation of the 'why' question. After all, finding a lasting solution begins with understanding the root cause of the problem. My management style is best characterized as coaching leadership: I position others in their strengths in order to perform well together. Analytical, disciplined and enthusiastic are qualities that I use daily in any field. In short: think first, then act! Feel free to join my professional LinkedIn network, or you can contact me directly. Looking forward to a prosperous connection! Ben Rusch T: +31 - (0)6 24 328 484 E: [email protected]
• Responsible for setting up and coordinating a remediation program to eliminate backlog in Non-Conformity Records in preparation for an IGJ GMP audit
General: • Contract Manufacturing Organization (CMO) specialized in the production of human plasma-derived medicinal products • Member of the Unit Management Team, Drugs Substance • Budget holder of the quality engineering team (OpEx input) • Direct manager to 8 FTE (on-site and remote) • Deputy for the VSM manager during his absence • Reporting to both the VSM manager and the VP, Manufacturing Drug Substance QE: • Accountable for the timely resolution of incidents, deviations, out-of-specifications, and CAPAs (MasterControl - eQMS) by the QE-team, related to product issues, environmental monitoring of production areas, and equipment calibrations • Establishing a robust QE-team at both tactical and strategic level to elevate quality standards • Ensuring compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDocP), and training • Analyzing quality issues (Power BI) and initiating improvement projects • Preparing and presenting monthly performance reports VSM: • Responsible for timely batch release • Chairing the daily VSM meeting with stakeholder departments (incl. SC, QA, QC, QE) • Preparing and presenting weekly client reports
General: • Contract Research Organization (CRO) specialized in the execution of (pre-)clinical oncology studies • Member of the management teams of three sites (NL+UK) • Member of the Global QAU • Stakeholder in international cross functional teams (CN, US, UK, NL, DE) • Direct manager to 1 FTE + functional manager to 1 FTE (both remote) • Reporting to the VP, Global Quality & Sustainability QA: • Accountable for the integral quality management systems (ISO 9001:2015) of three sites • Responsible for facilitating external audits • Responsible for the execution of internal audits, change controls, root cause analyses, and risk analyses (FMEA) • Responsible for site document compliance (Veeva Vault - QualityDocs) and site training compliance (Veeva Vault - Training) • Responsible for the timely resolution of complaints, deviations, and CAPAs (Veeva Vault - eQMS) • Preparing and presenting monthly performance reports QS: • Global Business Admin and Site Training Admin of the cloud based GxP system (Veeva Vault)
General: • Contract Development and Manufacturing Organization (CDMO) specialized in the supply chain operations related to packaging of cosmetics, disinfectants and detergents catering to both the consumer market and the professional market • Member of the site management team • World Class Manufacturing (WCM) team lead • Budget holder of quality department (CapEx + OpEx input) • Direct manager to 5 FTE (on-site) • Reporting to the Owner/CEO QA: • Accountable for the integral quality management system (ISO 9001:2015 + ISO 22716) • Responsible for the realization of internal audits, change controls, root cause analyses, and risk analyses (FMEA) • Responsible for updating quality related documents (including SOPs, specifications, validations) • Responsible for the registration and timely resolution of complaints, deviations, out-of-specifications and CAPA • Responsible for the development and implementation of an integral complaint registration system based on the 8D method • Implementing Hoshin Kanri for strategic planning of the quality department • Preparing and presenting monthly performance reports QC: • Responsible for all QC activities aimed at controlling process and product quality, in line with the operational quality management systems (incl. ISO 9001, ISO 14001, ISO 22716 (cosmetic GMP), ISO 13485) QS: • Automating business processes
General: • Contract Manufacturing Organisation (CMO) specialized in managing the supply chain operations related to packaging of dietary supplements • Budget holder of the QC department (CapEx + OpEx input) • Direct manager to 2 FTE (QC) • Reporting to the VP, Chief Quality and Regulatory QA: • Conducting internal audits, change controls, root cause analyses, and risk analyses (FMEA) • Drafting quality related documents (e.g. SOPs, specifications, validations) • Registering complaints, deviations, out-of-specifications and CAPA in the cloud bases GxP system (Veeva Vault - QMS) and resolve with suppliers QC: • Accountable for all QC activities related to monitoring process and product quality, in alignment with the operational quality management systems (incl. BRC, HACCP, GMP, SKAL) • Drafting and implementing key performance indicators (KPIs) • Implementing Balanced Scorecard (BSC) to monitor KPIs • Developing a planning tool to obtain better overview of the workload in the QC department • Preparing and presenting monthly performance reports QS: • Business Admin of the cloud based GxP system (Veeva Vault) • Migrating operational procedures, processes and documents to a digital platform (Veeva Vault - QualityDocs) • Developing a methodology and a digital registration system for acceptable quality limit (AQL) sampling for the purpose of final inspections of packaged products • Developing macro's in VB for optimization of a product database • Providing consultation for optimization (incl. SMED, 5S, A3) and digitization of the primary production process