Romano CAPANCIONI
Fermo
Summary
Results-driven quality assurance professional with a proven track record of maintaining high standards and achieving impactful outcomes. Proficient in process and cleaning validation, as well as technology transfer. Recognized for exceptional analytical thinking, problem-solving abilities, and effective communication skills that drive success.
Overview
20
20
years of professional experience
Work History
Quality Assurance Lead
GSK Vaccines
07.2021 - Current
- Provided oversight to ensure compliance to regulations for the following activities: Process Validation (across the 3 Stages), Cleaning Validation (across the 3 Stages), Container Closure Integrity Testing, Single Use System Validation, Technology Transfer, Extractables&Leachables risk management, Media Simulation/Filling, Final Product Visual Inspection, Validation of Sterile Filtration.
- Implemented continuous improvement initiatives within the QA team to elevate performance levels consistently across projects over time.
- Performed internal audits to maintain operating procedure and regulatory standards compliance.
- Participated to Regulatory Authorities Inspections
- Established and updated QA processes and metrics in line with industry best practices and project goals.
- Wrote, reviewed and approved documents to preserve quality assurance.
- Provided support for regulatory submissions
Cleaning Validation Supervisor
Takeda
07.2014 - 06.2021
- Led cleaning validation studies for new/existing equipment, verifying proper functionality before implementation into routine production.
- Ensured compliance with industry standards and regulatory requirements through rigorous validation processes.
- Participated to Regulatory Authorities Inspections
- Contributed to continuous improvement initiatives by identifying opportunities for process enhancements within the validation department.
- Trained new team members to quickly integrate into workflows.
- Applied strong leadership talents and problem-solving skills to maintain team efficiency and organize workflows.
- Conducted regular reviews of validation processes, ensuring adherence to established protocols while continuously seeking opportunities for enhancement.
Process Validation & Technical Service Specialist
Baxter Manufacturing S.p.A
06.2013 - 06.2014
- Authored process validation protocols and reports, verifying compliance with regulatory requirements
- Ensured adherence to industry best practices by staying current on relevant guidelines such as FDA 21 CFR Part 11 and EU GMP Annex 15.
- Assisted in the preparation of regulatory submissions by providing validation-related documentation, contributing to successful approval outcomes.
- Collaborated with cross-functional teams for identification and resolution of validation issues.
- Led technology transfer initiatives, enabling seamless integration of new products into existing production lines.
- Collaborated with cross-functional teams to ensure timely completion of validation projects, meeting regulatory requirements.
Process Validation & Technology Transfer Specialist
Sanofi S.p.A.
02.2012 - 05.2013
- Authored process validation protocols and reports, verifying compliance with regulatory requirements.
- Ensured adherence to industry best practices by staying current on relevant guidelines such as FDA 21 CFR Part 11 and EU GMP Annex 15.
- Collaborated with cross-functional teams to ensure timely completion of validation projects, meeting regulatory requirements.
- Assisted in the preparation of regulatory submissions by providing validation-related documentation, contributing to successful approval outcomes.
- Performed gap analyses between existing practices and required standards leading to the development of targeted action plans for compliance achievement.
- Conducted thorough root cause analyses to address deviations during validation activities, implementing corrective actions as needed..
- Collaborated with cross-functional teams for identification and resolution of validation issues.
- Led technology transfer initiatives, enabling seamless integration of new products into existing production lines.
- Collaborated with external partners to facilitate technology transfer initiatives, ensuring successful outcomes for both parties involved.
- Coordinated with global teams on technology transfer projects, ensuring seamless integration of new processes into existing facilities.
- Successfully completed numerous technology transfer projects between internal teams as well as external partners, resulting in seamless transitions without disruptions to ongoing operations.
- Conducted thorough risk assessments for proposed projects or changes in technology infrastructure, highlighting potential vulnerabilities before implementation could begin.
Medical Information Specialist - Monoclonal antibodies for autoimmune diseases
Janssen Biologics B.V. (J&J group)
01.2009 - 07.2011
- Received and documented medical inquiries from health care professionals, consumers and company departments
- Assisted healthcare professionals with accurate and timely information, ensuring best patient care.
- Developed comprehensive medical information materials for distribution to external stakeholders, such as healthcare professionals and patients.
- Verified accuracy of medical records to ensure high-quality patient data management.
- Collaborated with pharmacovigilance teams to ensure seamless reporting of adverse events related to company products.
- Conducted thorough literature reviews to support the creation of evidence-based responses for complex inquiries.
- Participated in industry conferences and workshops as a representative of the company, staying current on relevant trends and advancements within the field.
Laboratory Analyst
Leiden University
07.2007 - 12.2008
- Utilized advanced analytical techniques such as HPLC to provide accurate data for reports.
- Performed testing using approved laboratory procedures and instrumentation.
- Analyzed results using analytical software and created reports.
- Ensured proper handling of hazardous materials according to established guidelines for safe disposal or storage.
- Maintained documentation on tests performed in lab.
- Prepared reagents, media and solutions to use for laboratory testing and analysis.
- Maintained safe, tidy and organized laboratory environment for accurate test results.
Registered Pharmacist
Community pharmacies
07.2005 - 06.2007
- Dispensed and verified patient prescription orders, conducting necessary utilization reviews.
- Provided consultations and answered inquiries from patients, healthcare professionals and physicians regarding drugs, potential side effects, and specified use.
- Managed high prescription volumes under tight deadlines while maintaining accuracy standards essential for patient safety.
- Maintained a clean and organized work environment to promote safety, accuracy, and professionalism within the pharmacy setting.
Education
Master of Science - Pharmaceutical Chemistry And Technology
University of Camerino
Camerino, ItalySkills
- Strong analytical mind
- Teamwork and collaboration
- Attention to detail
- Problem-solving abilities
- Organizational skills
- Effective communication
- Decision-making
- Organized and detail oriented
- Professionalism
Accomplishments
- Collaborated in the implementation of Annex 15, Annex 1 and USP 665 requirements as Quality Assurance Lead
- Contributed to the transfer and validation of 10 manufacturing processes as Process Validation&Technology Transfer Specialist
- Supervised team of 4 staff members as Cleaning Validation Supervisor.
- Participated to the activities for two site expansions as Cleaning Validation Supervisor
- Managed a significant amount of deviations and CAPAs
Affiliations
- PDA (Parenteral Drug Association)
Languages
English
Advanced (C1)
Timeline
Quality Assurance Lead
GSK Vaccines
07.2021 - Current
Cleaning Validation Supervisor
Takeda
07.2014 - 06.2021
Process Validation & Technical Service Specialist
Baxter Manufacturing S.p.A
06.2013 - 06.2014
Process Validation & Technology Transfer Specialist
Sanofi S.p.A.
02.2012 - 05.2013
Medical Information Specialist - Monoclonal antibodies for autoimmune diseases
Janssen Biologics B.V. (J&J group)
01.2009 - 07.2011
Laboratory Analyst
Leiden University
07.2007 - 12.2008
Registered Pharmacist
Community pharmacies
07.2005 - 06.2007
Master of Science - Pharmaceutical Chemistry And Technology
University of Camerino
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