Daniela Rocca Email & Phone Number

Roma

Roma, Lazio, Italia

• Plan and conduct internal audits to verify the effectiveness of QMS • Prepare/ coordinate external audits• Perform supplier audits as required• Support/provide training to the organization about the ADD QS• Ensure QS record keeping, document control, Warehousing, QH, Supplier/ Distributor evaluation/ monitoring, CAPA management follow up and timely closure• Coordinate Field Communications at the Region• Ensure availability of org charts (including LSME if required) and… Show more • Plan and conduct internal audits to verify the effectiveness of QMS • Prepare/ coordinate external audits• Perform supplier audits as required• Support/provide training to the organization about the ADD QS• Ensure QS record keeping, document control, Warehousing, QH, Supplier/ Distributor evaluation/ monitoring, CAPA management follow up and timely closure• Coordinate Field Communications at the Region• Ensure availability of org charts (including LSME if required) and JDs• Ensure the setting and tracking of the Training Plan for all positions• Assess risk related to processes• Timely escalate regional concerns to Area Management Review and MIMS MR• Supports Global Commercial Affiliates QA improvement projects• Maintain/ challenge current certifications. Propose new certificates if required• Coordinates communication between commercial organization and Regulatory to support responses in contracts and public tenders (QARA, EHS requirements)• Team/ MIMS Subject Matter Expert & Procedure Owner• Review Abbott policies & procedures, and update Quality docs accordingly• Manage any audit input by initiating changes to affected processes following MIMS change control procedures• Identify and coordinate improvement initiatives within the entire QS• Participates in QS improvements and implementation projects• Actively seek internal/external customer feedback and respond to issues• If there is no regulatory function in the affiliate, perform/ ensure revision and approval of locally/translated AdPromo material on behalf of Regulatory Affairs. • Manage the QA budget, always considering cost improvement opportunities• Act as an expert for sales and customer support for accreditation topics, presentations and process implementation in sites where customer certification / accreditation is requested Show less

Roma, Italia

• Ensure Quality System awareness and compliance in the affiliate/ Region/ EMEAP HQ• Plan and conduct internal audits/ assessment to verify the effectiveness of the management system • Perform supplier audits as required. • Prepare/ coordinate external audits. • Receive audit input and follow QS Document Control if applicable• Support/provide training to the organization about the ADD Quality System.• CAPA management follow up and ensure timely closure.• Actively… Show more • Ensure Quality System awareness and compliance in the affiliate/ Region/ EMEAP HQ• Plan and conduct internal audits/ assessment to verify the effectiveness of the management system • Perform supplier audits as required. • Prepare/ coordinate external audits. • Receive audit input and follow QS Document Control if applicable• Support/provide training to the organization about the ADD Quality System.• CAPA management follow up and ensure timely closure.• Actively seek internal/external customer feedback and respond to issues. • Ensure QS record keeping, Warehousing, QH, Supplier / Distributor evaluation/ monitoring.• Coordinate Field Communications at the Region. • Ensure availability of org charts (including LSME) and job descriptions.• Ensure the setting and tracking of the Training Plan for all positions. Maintain continuous vigilance upon the employee compliance with trainings, to contribute prevent late trainings.• Assess risk related to processes• Timely escalate regional concerns to EMEAP Management Review and feed MIMS MR• Ensure compliance of local documents • Supports Global Commercial Affiliates QA improvement projects• Maintain/ challenge current certifications.• Coordinates communication between commercial organization and Regulatory to support responses in contracts and public tenders (QARA, EHS requirements).• Team/ MIMS Subject Matter Expert & Procedure Owner: o Be the expert on a QS process and support the rest of team as process SME: either as lead, backup or team member. o Be part of division process community and remain in contact with division process owner to provide input and suggestions on that process. (international contact)o Review Abbott policies & procedures, and update QS documentation accordingly.• Manage the QA budget, always considering cost improvement opportunities Show less

Roma, Italia

Coordinate/ ensure Quality Assurance and Regulatory Assurance services across several European countries.Coordinate/ ensure EU and region supplier evaluation and monitoring with the team Review EU and Regional laws & regulations (including Environmental, Health & Safety) with the Regulatory Affairs team. Evaluate/ describe consequences for the company and act accordingly.Respond to regulatory requests from authorities across countries. Monitor open European Union and Region CAPA and… Show more Coordinate/ ensure Quality Assurance and Regulatory Assurance services across several European countries.Coordinate/ ensure EU and region supplier evaluation and monitoring with the team Review EU and Regional laws & regulations (including Environmental, Health & Safety) with the Regulatory Affairs team. Evaluate/ describe consequences for the company and act accordingly.Respond to regulatory requests from authorities across countries. Monitor open European Union and Region CAPA and ensure timely closure.Ensure distributors compliance with EHS EU legislation.Review & approve global/ EU advertisement and promotional material in English for all theEU/EFTA countries. Likewise ensure the review and approval of locally developed advertisement and promotional material.Ensure Quality System implementation, effectiveness and compliance:o Perform internal, supplier/ distributors audits. Prepare/ coordinate external audits.o Ensure Quality System record keeping, Warehousing quality compliance, Quality Holds.o Actively seek internal/external customer feedback and respond to issues.Medical information Management System Subject Matter Expert & Procedure Owner:o Review policies & procedures, and update Quality documentation accordingly.o Receive audit input and follow QS Document Control Process.Support commercial organization in contracts and public tenders (QARA, EHSrequirements). Show less

Roma, Italia

Preparation of all Quality Management System (QMS) documentation ensuring its follow-up and implementation; Update, distribution and archiving of all documentation of the QMS (Quality Manual, General Procedures, Standard operating Procedures, Technical files, Risk analysis, Labelling, Performance Evaluation, Stability Studies); Management of EN ISO 13485 and 9001 Certification;KPI Analysis and drafting Management Review Report;Complaints handling and management of non-conforming… Show more Preparation of all Quality Management System (QMS) documentation ensuring its follow-up and implementation; Update, distribution and archiving of all documentation of the QMS (Quality Manual, General Procedures, Standard operating Procedures, Technical files, Risk analysis, Labelling, Performance Evaluation, Stability Studies); Management of EN ISO 13485 and 9001 Certification;KPI Analysis and drafting Management Review Report;Complaints handling and management of non-conforming products promoting CAPA; Management of Internal and External Audits;Registration of IVD, CE mark and Release to market; Point of Contact with Certification Bodies, Notified Bodies and Competent Authorities (Italian and foreign); Submitting IVD Registration to Competent Authorities (Italian and worldwide); Post-Market Surveillance; customer's feedbacks and Recall from the market;Report potential incidents and incidents to the Competent Authorities and the Notified Body;Management of activities related to Safety and Privacy (Dlgs 81/2008 and 196/2003);Management activities of Quality Control Department on raw materials, semi-manufactured and final goods;Incoming inspections on critical diagnostic products;Application and evaluation of diagnostic kits on automatic instruments and software validation;Collaboration with customers, distributors, technical service and suppliers for post-sales support. Show less

Pomezia

Management Customer Care and post-sale support;Collaboration with sales force, suppliers and distributors;Collaboration with technical service for problem solving;Training to customers and distirbutors on IVD kits and instruments;Management of technical documentation and promoting material.