Copenhagen, Capital Region of Denmark, Denmark
My name is Claudia Guadalupe Ricci, and I am recognised for achieving positive outcomes. I have a proven ability to deliver results through collaboration and innovative thinking when leading cross-disciplinary teams. I am an enterprising QA professional with a penchant for surpassing expectations. Throughout my career, I have built a reputation as a transformational leader who is driven by challenges and undeterred by obstacles. I am committed to raising standards of excellence. My expertise encompasses all aspects of quality assurance, product testing, and laboratory management in the pharmaceutical, biopharmaceutical, and medical devices industries. As a certified GMP and ISO (9001, 14001, 13485 and 17025) auditor, I am highly experienced in conducting ISO, MDR and GMP audits as a lead auditor. In addition, I have a proven track record of successfully building consensus among executive teams and stakeholders to promote transparency and encourage positive change. I am an excellent communicator and problem solver with a solid track record of achieving both personal and shared goals.
Represent Investment Portfolio QA in cross-organizational projects. Direct and teach others about the impact of own key information on the Novo Nordisk business Inspire and engage colleagues and peers, and drive transfer/sharing of knowledge across area and with other expertise areas. Identify and implement possibilities for improvements including use of new tech. tools. Uses best practices and knowledge of internal or external business requirements to improve processes. · Responsible for running cross-functional projects across training and process management within NN Investment Portfolio QA (IPQA). Project Manager for relevant cross-functional organizational projects within IPQA: · Conduct quality project assessment (project evaluations) for large Investment projects, overseeing validation lifecycle activities to safeguard product quality & patient safety. · Supplier Audits. Participate in Audits as lead auditor · Implementation lead for Veeva Quality Vault platform for processes such as deviations, change control, audits, QMT (quality monitoring trends) and batch records
Lead and manage project quality activities for large, complex, and multi-disciplinary projects. Develop and implement project verification strategy, including alignment with the customer's quality system and validation approach. Plan and execute process confirmations to ensure compliance with procedures and specifications. Provide direction for our quality activities and ensure alignment across project disciplines. Participate in the coordination and facilitation of e.g. supplier management activities, providing guidance and follow-up on supplier quality deliverables
Responsible for the Quality Assurance department leading the department to create QMS according to ISO 13485/ 21 CFR part 820 and MDR, including SOPs, process monitoring, audits, etc. Ensure compliance in EU, US and other markets. Drive root cause investigation of deviations and customer complaints. Develop and drive the organization’s CAPA activities. Lead and train the organization to ensure compliance. Plan and carry out audits and monitoring activities with suppliers. Act as the quality representative to the management team. Responsibilities include conducting internal and external audits (as Lead Auditor), creating internal audit plans, carrying out internal audits across all departments, and training QA staff to become internal auditors in accordance with ISO 13485, 9001, MDR and FDA standards. As the QA and RA lead, I obtained re-certification for ISO 13485 and was responsible for preparing the entire company for MDR certification (creating GAP analysis MDD-MDR, update the QMS according MDR, etc).
Starting up creating and implementing of QMS according GMP and ISO guidelines in new Analytical services Laboratory in the Medicinal Cannabis field. I am overall responsible for ensuring a high level of compliance, hands-on quality, and long-term quality controls according to standards used in the organization across the Food and Feed product portfolio. In my role, I manage the international quality policy and quality system (QMS), while also ensuring that analysis and suppliers adhere to the high-quality requirements. I am leading IT system, LIMS and operative’s validation and qualifications.