Lucerne, Lucerne, Switzerland
Having had the opportunity to cover two of the key roles in sterile production, quality and tech, I improved the perception of the sterile process in a transversal way; taking the most from the roles. As external manufacturer I improved my communication skills, being very diplomatic and reliable. Considering myself as hard-working person, with a great ease of adaptation in cross-cultural environments and the aim to always improve.
• Lead technical operations for contract manufacturing organizations (CMOs), achieving increase in production efficiency through effective project management and process optimization. • Served as Project Management Lead for a major sterile manufacturing CMO, successfully driving two new source of supply (SoS), three New Product introduction, and the set-up of new packaging lines. • Served as the primary technical contact for external manufacturing sites, ensuring strict compliance with regulatory requirements and company policies. Managed two critical investigations related to sterility failures, leading GEMBA activities and comprehensive fact-finding efforts that identified root causes and implemented corrective actions. • Collaborated with cross-functional teams in strategic decision-making, leading to the successful implementation of initiatives that enhanced product quality and manufacturing process. • Responsible for all tasks described in the below Sr. Specialist role
• Acted as the technical reference for all ongoing projects across two CMOs, providing expert guidance and support to ensure project alignment with quality standards, regulatory requirements, and operational objectives. • Collaborated closely with Quality Assurance, Supply Chain, Regulatory Affairs, and Regional Leadership teams to drive alignment on quality standards, streamline processes, and ensure compliance with regulatory requirements, resulting in enhanced operational efficiency and improved product quality. • Became a Subject Matter Expert on Visual Inspection processes, presenting findings at the PDA Visual Inspection Forum, which resulted into an high reduction of false negative. • Responsible for all tasks described in the below Specialist role.
• Oversaw Continued Process Verification (CPV) initiatives across four CMOs, ensuring adherence to quality standards and regulatory compliance. • Served as the primary contact for both internal and external reviews, effectively managing change control processes to facilitate seamless operations and minimize disruptions. • Reviewed and analyzed deviations, Corrective and Preventive Actions (CAPAs), Annual Product Reviews, and risk assessments, driving continuous improvement and ensuring product quality. • Provided on-site support during production, acting as a key liaison between manufacturing teams and quality assurance to resolve issues promptly and maintain operational efficiency. • Executed comprehensive technical due diligence assessments at two CMOs, evaluating capabilities and compliance to support strategic partnership.
• Conduct thorough evaluations of products to ensure compliance with all applicable policies, procedures, and regulatory requirements, thereby upholding the highest quality standards. • Effectively manage routine and complex deviations by implementing corrective actions and preventive measures to minimize recurrence and enhance product integrity. • Coordinate significant investigations, fact-finding missions, and product recalls to promptly address quality issues and mitigate risks to product safety and efficacy. • Provide expert quality support during self-inspections, internal audits, and regulatory inspections at contract manufacturers to ensure compliance with all quality standards and requirements. • Collaborate closely with key stakeholders, including Technical Operations, Supply Chain, Regulatory Affairs, and Regional Leads, to foster a unified approach to quality management. • Monitor and analyze Key Performance Indicators (KPIs) such as Right First Time, Deviation Cycle Time, and Customer Complaints to assess quality performance and drive continuous improvement initiatives.
My main responsibilities were: • Drafting, reviewing and issuing methods, material specifications and protocols • Responsible to provide the correct documentation at the entire facility • Responsible for the reconciliation of expired documentation and operator training • Master Batch Record review
My main responsibilities were: • Drafting, reviewing and issuing methods, material specifications and protocols with focusing on stability protocol (ICH; Bulk holding time; Annual), • Drafting of Certificate of Analysis and product specifications • Inform and manage Notification of Regulatory Approval (NORA) provided by the relevant authorities/countries
My main responsibilities were: • Interpersonal relationships • Promotion and presentation of the products in details with demonstration • Strong technical-commercial skills • Punctuality and cordiality • Participated in a various incentive programs and contests designed to support achievements of production goals