Manager, Distribution and Regional Quality, New Markets
Beigene Brasil Ltda (Jul/2023 - Present).
- Responsible Person (Pharmacist) in charge of the warehouse facility.
- In country disposition/ release activities for Brazil market and issuance of Certificate of Compliance for product commercialization.
- Support commercialization and clinical trials in New Markets for all BeiGene and partner products and deliver high-quality products to our patients, in compliance with Good Manufacturing Practice (GMP) Good Distribution Practice (GDP) requirements.
- Perform quality oversight for local distribution activities in New Markets.
- Support activities for market action and product recall (mock recall) in New Markets.
- Review and approve product complaints, temperature excursions, deviation investigations and CAPA plan.
- Perform Due Diligence visits for local distributors and Quality oversight for local secondary distributors (wholesale dealers).
- Provide Quality support to implement robust and transparent Quality Governance review processes such as Management Review and Quality Review Board.
- Provide Quality guidance of cGMP/GDP for cross functional groups to ensure compliance with KPI targets including functional Quality as required.
- Assess and revise, as needed, SOPs for GMP/GDP Quality functions and identify opportunities to streamline systems and processes.
- Monitor performance metrics and drive continuous improvements of internal processes.
- Implement and manage Quality Assurance System and QMS.
- Maintain local quality procedures and input into global policy, SOP, and guideline development.
- Qualification and oversight of 3rd party providers – audits, quality agreements, monitoring activity, participate in KPI and business reviews.
- Participate/ respond to corporate audits and self-assessments and self-inspection for Brazil.
- Management of temperature sensitive products including lane qualifications, shipper qualification, temperature excursion assessments, transport validation.
- Quality subject matter expert for ANVISA and VISA inspection and communication.
- Perform Gap assessments to ensure alignment to ANVISA and VISA requirements.
- Manage and/or approve relevant change control relating to Brazil product (new product introductions/lifecycle changes/distribution readiness).
- GxP training content development and delivery for Brazil staff.
- Provide support to Supply Chain with activities of interface, as needed (return of goods, temperature excursion, others).
- Brazil point-of-contact/SME for global networks.
- Participate in the Annual Product Review.
- Quality input into state based, commercial tenders and/or hospital formulary.
Quality Assurance & Compliance Coordinator.
Bristol Myers Squibb (Jan/2022 - Jun/2023).
- In country disposition/ release activities for Brazil market and issuance of Certificate of Compliance for product commercialization.
- Responsible for contact CMOs in cases of issues detected during local warehouse activities in regard to imported products.
- Support CMOs investigations, as required.
- Evaluation of temperature loggers during the importation of products, temperature excursion assessments.
- Responsible to issue the temperature loggers assessment for biologic products for custody term release by ANVISA.
- Responsible for the change control impact assessment and required activities for new product introductions in Brazilian market.
- Responsible for coordinating local mock recall activities.
- Responsible for sample retention room, inventory management.
- Management of the deviation system, approve CAPA plan and root cause analysis.
- BMS Trainer/Coach for root cause analysis (Instructor).
- Responsible for reporting Quality metrics and monthly market updates, prepares Deep Dives and trending analysis.
- Learning management system administrator of local GMP/GDP training programs and curriculums for GxP functions.
- Management of Quality system documentation acting as a local administrator.
- Management of QMS compliance on site.
- Certified BMS Auditor for warehouse and distribution centers, GMP support services and third-party laboratories.
- Qualification of third parties (suppliers, distributors (wholesale dealers) and service providers), issuance of audit reports, approve and follow-up of CAPA plans and establish Quality Agreements.
- Prepare the site annual self-inspection plan, perform internal audits, issuance audit reports, coordinate and track corrective/preventive actions.
- Lead preparations for Health Authorities inspection.
- Lead preparations and participate of corporate/global audits.
Quality Assurance Coordinator
Celgene Brasil Ltda (Apr/2018 - Dec/2021).
- Responsible Person (Pharmacist) in charge of the warehouse facility.
- In country disposition/ release activities for Brazil market and issuance of Certificate of Compliance for product commercialization.
- QA logistics activities at the Logistic Operator facility (inbound process of finished goods, storage, sampling process, temperature excursions and environmental monitoring conditions).
- Implementation of QMS at the warehouse facility and QC lab.
- Implementation of Business Continuity Plan for warehouse and laboratory facility.
- Responsible for coordinating local mock recall activities.
- Support annual inventory activities.
- Support product quality complaints and return of goods.
- Support and maintenance of necessary operating licenses for the warehouse and QC lab.
- Management of the Deviation system, approve CAPA plans and root cause analysis.
- Management of the Change Control system.
- Qualification of third parties (suppliers, distributors (wholesale dealers) and service providers), issuance of audit reports, approve and follow-up of CAPA plans and establish Quality Agreements.
- Prepare the site annual self-inspection plan, perform internal audits, issuance of audit reports, coordinate and track corrective/preventive actions.
- Management of Validation Master Plan of QC lab.
- Management of local projects with regards to Computerized System Validation & Data Integrity.
Corporate PMO Sr Analyst (Jan/2018 - Apr/2018).
Libbs Farmacêutica Ltda (Jun/2015 - Apr/2018).
- Kick-off meeting of new development projects to define objectives, resources, restrictions, deadlines, and project schedule.
- Conduct product development meetings through the interface with stakeholders.
- Management of project milestones. Monthly reports to the Director and Area Manager.
Position: Validation Analyst (Jun/2015 - Dec/2017).
- Support GMP & self-inspection audits.
- User Requirements revision regarding business and ANVISA, FDA 21 CFR Part 11 requirements.
- Execution of computerized system validation of automation equipment at the manufacturing site.
- Validation Master Plan maintenance and software inventory.
- FAT and SAT qualifications.
- Cloud systems validation and go-live of drug traceability systems.
- Media fill tests execution of biological & oncological products.
- Support yellow fever vaccine project regarding transport validation activities.
Validation Analyst (Apr/2014 - Jun/2015).
Laboratórios Baldacci LTDA (Apr/2013 - Jun/2015).
- ERP system key-user.
- Administrator role of learning management system.
- Administrator role of the document management system.
- Validation Master Plan maintenance and software inventory.
- Go-live of Quality systems (i.e., Deviation, CAPA, and Change Control systems).
- Support Supplier Qualification process, including audits and final reports.
- Support Self-inspection plan and exercises.
Quality Assurance Analyst (Apr/2013 - Mar/2014).
- Administrator role of learning management system.
- Perform Periodic & Annual Product review and issue reports. Perform process analysis through Minitab statistical software.
- Support during cleaning validation activities, as well as equipment visual inspection, swab and rinse-testing after cleaning process of manufacturing equipment, campaign validation, etc.
- Revise SOPs and WIs, as well as to conduct training. Management of training matrix and training schedules. Training adherence verification and compliance.
- Reverse osmosis water system startup and performance of qualification tests with the system vendor.
Validation Analyst.
Farmoquímica LTDA (Jul/2011 - Apr/2013).
Validation Intern.
(Hypermarcas Group) (Mar/2010 - Jun/2011).
