WINNIA FRANCISCA FURTADO

• Partnered with the markets team to design and lead consulting initiatives, delivering customized solutions and CSV services across the pharmaceutical, food, and medical device industries.
• Developed proposals, led calls and meetings and actively participated in business pitches to effectively present service offerings to prospective clients.
• Led the preparation of an independent report for the Indian Drug Manufacturers Association (IDMA), highlighting MSME challenges in the pharmaceutical sector, to be presented to the Ministry of Commerce & Industry.
• Collaborated with stakeholders to design tailored solutions that addressed client-specific challenges.
• Oversaw project delivery, ensuring alignment with organizational objectives and quality standards.
• Fostered relationships with key stakeholders to ensure alignment on strategic objectives and project outcomes.
• Mentored junior staff members, providing guidance on professional development opportunities and career progression paths within the company.

• Directed SAP S/4 HANA & SAP RISE (Cloud ERP) validation projects for global pharmaceutical companies.
• Led plant gap assessments for shop floor manufacturing, QC applications, and packaging equipment.
• Delivered steering committee updates to senior global stakeholders.
• Developed and implemented risk management frameworks, ensuring compliance with regulatory standards and best practices.
• Led cross-functional teams to achieve project milestones and deliver high-quality results.
• Collaborated with senior leadership to shape business strategy and drive growth initiatives.
• Established strong relationships with clients and stakeholders, ensuring long-term partnerships and repeat business.

• Led SAP validation projects for domestic and global pharmaceutical clients, as well as a global cosmetics company.
• Prepare proposals and participate in meetings and discussions with potential clients during the early pursuit phases.
• Manage project engagements by reviewing documentation and providing technical guidance to team members.
• Prepare and attend steering committee meetings to align project goals and progress.
• Oversee multiple SAP S/4 HANA and SAP RISE (Cloud ERP) validation projects.
• Conduct manufacturing plant gap assessments and lead validation of shop floor manufacturing systems, primary and secondary packaging equipment, BMS, and QC applications.
• Plan and manage resources strategically to ensure efficient project delivery.

• Reviewed SAP validation projects for large domestic and international pharmaceutical clients, as well as medical device and diagnostic device manufacturing companies.
• Perform 21 CFR Part 11 and EU Annex 11 compliance assessments for GxP computerized systems for leading global pharmaceutical organizations.
• Oversee plant validation of production line equipment to re-establish manufacturing for the US market.
• Support an international medical device company as a Global CSV Subject Matter Expert (SME) for SAP S/4 HANA validation in alignment with USFDA, EMA, NMPA, and MHLW regulatory requirements.
• Lead a comprehensive IT QMS implementation and dossier development project for a serialization and aggregation vendor of a major pharmaceutical client.
• Conduct GLP quality audits (QC and Microbiology) for a leading pharmaceutical company across domestic and international manufacturing sites, loan license facilities, and during data integrity investigations.
• Review Computer System Validation (CSV) documentation for systems including SAP, Electronic Lab Notebooks (ELN), and laboratory instrumentation software.
• Evaluate and approve deviations, change controls, and CAPA records to ensure regulatory compliance and continuous improvement.
• Ensure adherence to global regulatory standards and guidelines as per GAMP 5.
• Design and implement enhanced controls for analytical instruments based on audit observations to strengthen data analytics and integrity.
• Execute SAP validation projects, including global system rollouts and plant assessments, ensuring consistent GxP compliance across sites.

• Supported Computer System Validation (CSV) projects for the revalidation of SAP ECC systems.
• Conducted 21 CFR Part 11 and EU Annex 11 compliance reviews, along with GxP and risk assessments to ensure regulatory alignment for 50+ GxP systems by establishing prioritized remediation roadmaps.
• Performed CSV pre-assessment reviews for 2 international pharmaceutical clients prior to SAP implementation to identify compliance gaps and readiness.

Apr 2016 – Sep 2017 (Assistant Manager)

• Handled Quality Assurance responsibilities with a primary focus on Computer System Validation (CSV), non-CSV installations, and user privilege validations.

Jun 2015 – Mar 2016 (Assistant Manager)

• Led the implementation of the Documentum software for managing change requests, including preparation of IOPs and SOPs.
• Conducted user training sessions in the laboratory, created user logins, and served as the single point of contact for system-related queries.
• Spearheaded Computer System Validation implementation from its initiation phase, ensuring compliance with regulatory standards.
• Performed administrator duties for 21 CFR Part 11–compliant laboratory software systems.

Jan 2014 – May 2015 (Management staff)

• Independently managed Quality Assurance functions for a laboratory, ensuring all compliance and documentation requirements were met.

Apr 2013 – Dec 2013 (Management staff)

• Acted as project coordinator to ensure seamless cross-functional collaboration between R&D formulation and Analytical development laboratories for timely process completion.
• Ensured necessary requirements and resources were in place for initiating development activities.

Dec 2009 – Mar 2013 (Management staff)

• Prepared schedules and reviewed in-house calibration reports to maintain equipment compliance.
• Reviewed third-party calibration reports for accuracy and adherence to standards.
• Evaluated personnel validation records and installation checks.
• Verified training files and ensured timely issuance and log maintenance of QA documentation