Roberto Resende

• Sr. Quality Specialist, CQSC, Alexion AstraZeneca Rare Diseases, Dublin, Ireland, 03/2022, 07/2023, Responsible for supporting the audit and internal inspection function by managing the end-to-end process for audits and inspections, including preparation, conducting, and approval. I led the response commitment process (CAPAs, Deviations, Observations, and comments.), ensuring the responses were submitted on time and that best practices and guidelines were followed and/or implemented. Supported the GMP/GDP Audit / Health Authority inspection program, including but not limited to: Support key stakeholders during the preparation and management of audits/inspections (CLOs (testing), CDMOs (Medical device), Materials (Excipient, Raw materials), CDOs (Packaging, Distributor), CMO (Manufacturer release). Supporting and managing external and internal inspections for GMP and GDP was one of the key responsibilities – which involved Audit schedule, selecting third-party auditors, and ensuring their training, qualification, and experience are up-to-date and aligned with the audit. Responsible for preparing the audit package, including information and documents, such as quality agreements (Alexion vs. supplier) and previous audit outcomes. Another important responsibility is reviewing and approving audit agendas and reports. CAPA Management: Review, approve, and accurately enter all necessary information into the Quality Management System (TrackWise). This includes a thorough review of issued Audit Reports and a commitment to follow up on all CAPA actions until the issue is resolved and officially closed in TrackWise. Track and lead CAPA responses (around 150 Audits plus over 25 Internal Inspections), ensuring auditees submit for review, updates, approval, and closure within 30 days of the audit report’s issue. I support reviewing and reporting quality metrics, including a monthly/quarterly report summarizing all Audit Reports issued that month/quarter, highlighting the number of Critical, Major, and Minor Observations/Findings, as a crucial tool for identifying trends and areas for improvement. This, in turn, enables the organization to take decisive actions to keep and enhance the quality. Collaborate with relevant stakeholders to gather necessary feedback for the efficient functioning of the audit/inspection function. Serve as the primary point of contact for audit/inspection inquiries from stakeholders. Contribute and lead continual compliance enhancement initiatives within the team. Provide review and approval for Standard Operating Procedures (SOPs), and Work Instructions (WI).
• Compliance Officer, PLG, Dublin, Ireland, 05/2021, 03/2022, Responsible for coordinating activities and assisting Group Servier (IRIS) R&D-QA & the auditors' team on Corrective and Preventive Action (CAPA) management from the agreement until its closure. I manage CAPAs related to Good Clinical Practice (GCP) and Good Vigilance Practice (GVP), ensuring strict compliance with the legislation. Additionally, I triaged, assessed, processed, and assisted a team of auditors worldwide. Responsibilities include but are not limited to: validating CAPAs that are under agreement, collecting CAPA Plans approved, and following up on any CAPA Plans from the Audit Responders. I review the proposed follow-up actions and any associated evidence, document, review and close out CAPA plans related to GCP and GVP. If actions are ready to be closed, I document the close-out of the action with appropriate evidence. If actions cannot be closed, I document the review and expectations for the action, guiding the Audit Responders on how the task should be performed. I was also responsible for evaluating and accepting Date Extension requests for action implementation, monitoring CAPA due date, escalating any overdue CAPA Plans/Actions, documenting the CAPA review of Major and Critical Findings through the CAPA system tool, and filling the documentation in the concerned SharePoint. Furthermore, I am accountable for periodic reporting to the Head of the audit department of CAPA closure progress, creating and maintaining a list of CAPAs open, closed, and overdue, including a list of audits open and closed since the previous reporting (previous fiscal years).
• Pharmacovigilance Operations Specialist, IQVIA, Dublin, Ireland, 03/2019, 09/2020, As a Regulatory Reporting Case Processor, the main responsibility is administering regulatory activities while ensuring strict compliance with the country's legislation, International Conference on Harmonization - Good Clinical Practice (ICH-GCP), and Good Pharmacovigilance Practice (GVP) modules. Also responsible for triaging, assessing, and processing lifecycle safety information across multiple countries/sites. As a Regulatory Reporting Quality Subject Matter Expert (SME), I ensured the timely submittal of safety information by filing and managing submission documents in the ECM repository, creating and uploading submission packages to the Argus database, and prioritizing reports. Driven quality through compliance, consistency, and adherence to SOPs while coaching junior team members to ensure strong ethics and compliance. Categorized the reportability of cases by analyzing safety data against regulations per country and assisting with the reconciliation of adverse event reports from all sources. Generated periodic benefit-risk evaluation reports (PBRERs), developed safety update reports (DSURs), and line listings to reinforce the safe marketing of drugs. Processed reports in accordance with the regulatory intelligence database, MPMP, and QRGs, while reviewing and maintaining periodic report listings provided by Local Office Contacts (LOCs).
• Pharmacy Technician, Hickey’s Pharmacy, Dublin, Ireland, 01/2019, 03/2019, Partnered with pharmacists to provision exceptional customer service face-to-face and via phone, dispensing and delivering medications, referring inquiries to pharmacists, and responding to questions from patients and providers. Produced timely reports, updated prescriptions and physician order records, and oversaw inventory control. Executed operations in tandem with the team, inclusive of calculating and issuing charges. Upheld safety and cleanliness whilst adhering to rules, regulations, procedures, and infection-control policies and protocols.
• Content Analyst, Arvato Financial Services, Dublin, Ireland, 07/2017, 10/2018, Advised clients on increasing advertising effectiveness in the Portuguese market according to the evaluation of Google AdWords content and data – up to 270-pages daily. Liaised with clients during meetings, recommending strategies to drive productivity levels based on analysis of findings. Studied Google products - AdWords Dynamic Callouts, Prince Extension, and Sitelink. Assimilated new hires into the workplace, playing a key role in fulfilling 96 to 100% of targets and enhancing
• Supervisor, Quiz Clothing, Dublin, Ireland, 10/2015, 07/2016, Energized a team of seven shopping assistants through coaching, training, and motivation, clearly communicating tasks and executing performance evaluations with constructive feedback. Optimized resources through budget planning, authorized merchandise returns and payments and supervised shipment and order processing.
• Supervising Pharmacist, Drogaria Catarinense – CLAMED, Santa Catarina, Brazil, 12/2012, 06/2015, Shaped a cohesive work environment by supervising 19 pharmacy technicians, six over-the-counter (OTC) assistants, and three pharmacists whilst ensuring quality and security by implementing standard procedures. Administered product training to employees, aligning materials with good manufacturing practices (GMP). Enhanced customer experience, answering inquiries, sharing product knowledge, and aiding customers, averaging 50 to 80 daily, in finding merchandise. Engaged the public and customers during workshops with 20 to 30 attendees. Regulated paperwork, generated reports and updated batch records. Oversaw inventory control, ensuring proper supply levels and tracking expiration dates. Received c. £30k in cash and credit card sales on a day-to-day basis, whilst strategizing with management on creating in-store programs to drive sales. Minimized risk by adhering to and enforcing compliance with federal laws, state regulations, and company policy/procedure; complied with legal documentation requirements. Directly contributed to 17% growth in pharmacy services within an already high-performing team by marketing private services, building strong relationships with external referrers, and achieving items growth targets.

As a Senior Quality Specialist at Alexion Pharmaceutical/AstraZeneca Rare Diseases' Global Audit & HA Inspections, I managed the end-to-end process of Audits, CAPAs, and Deviations for a diverse portfolio (GMP/GDP) worldwide. Working with suppliers and other Alexion sites, I was able to ensure compliance with regulatory requirements while identifying opportunities for continuous improvement. I also have served as a Compliance Officer (CAPA Management) on an extensive GCP & GVP audit portfolio, managing, following up and driving CAPAs (Critical, Major and Minor Observations/Findings) to their closeout following the current legislation working along with many third-party sites worldwide where I could improve my active listening, empathy, leadership, and teamwork skills. I have also acted as a Pharmacovigilance Specialist on a comprehensive portfolio of work involving numerous clinical trials and post-marketing studies across various indications, providing regulatory advice and support to internal and external customers from development through full life cycle management. Experience in the GCP-GVP and regulatory reporting subject with demonstrated knowledge of scientific principles, e.g., R&D, Quality, and Clinical Research. Client-focused approach with attention to detail, strong organizational skills, and prioritizing multiple projects. Languages: Portuguese – Mother Language | English – Full professional proficiency.

• Training Program – Certificated in MD-QMS ISO 13485:2016 – Foundation Training - Irish Quality Centre
• Completed Internal Auditor Training Course – Inspired Pharma Training
• Certificate in Manual Handling FETAC Level 6 and Food Safety Level 1 at Skills Team
• Completed an intensive internal trainee for Management and Leadership
• Completed qualifications in Adobe Acrobat, Microsoft Office (Microsoft Word/Excel/PowerPoint), TrackWise, Veeva Vault, BOX, Qlik, Citrix, Argus, Prism, OPAL, eTMF, SmartSheet, EQV, DocuSign, SABA, Teams
• Completed qualification in skin care cosmetics such as: Vichy, La Roche Posay, Eucerin, Neutrogena, SkinCeuticals , Avene
• Completed qualification in General English Course from Griffith College, Dublin, Ireland
• Completed a qualification in Business-To-Business: Sales course from in Learning, LinkedIn
• Completed qualification in Working with Upset Customers course from in Learning, LinkedIn
• Completed qualification in Leading without Formal Authority course from in Learning, LinkedIn

Training Program – Certificated in MD-QMS ISO 13485:2016 – Foundation Training - Irish Quality Centre

Completed Internal Auditor Training Course – Inspired Pharma Training

Certificate in Manual Handling FETAC Level 6 and Food Safety Level 1 at Skills Team

Completed an intensive internal trainee for Management and Leadership

Completed qualifications in Adobe Acrobat, Microsoft Office (Microsoft Word/Excel/PowerPoint), TrackWise, Veeva Vault, BOX, Qlik, Citrix, Argus, Prism, OPAL, eTMF, SmartSheet, EQV, DocuSign, SABA, Teams

Completed qualification in skin care cosmetics such as: Vichy, La Roche Posay, Eucerin, Neutrogena, SkinCeuticals , Avene

Completed qualification in General English Course from Griffith College, Dublin, Ireland

Completed a qualification in Business-To-Business: Sales course from in Learning, LinkedIn

Completed qualification in Working with Upset Customers course from in Learning, LinkedIn

Completed qualification in Leading without Formal Authority course from in Learning, LinkedIn