Overview
Work History
Education
Skills
Websites
Research and Presentations
Software
Professional Society Memberships
References
Timeline
Generic

Susan Ndungú

Overview

9
9
years of professional experience

Work History

Entrepreneurial Venture and Caregiver Break

SELF-EMPLOYED
01.2023 - Current
  • Took a voluntary break in my career to offer dedicated care to a family member facing health challenges
  • Initiated and successfully managed a personal entrepreneurial venture, honing skills in business development, client relations, budgeting, and negotiation
  • Cultivated a results-driven mindset and a strong sense of initiative through hands-on business experience
  • Stayed professionally current by actively participating in webinars hosted by esteemed industry experts, ensuring up-to-date knowledge of regulations and industry developments
  • Enrolled in a specialized course concentrating on advanced quality assurance methodologies and pertinent ISO standards in pharmaceutical quality management, showcasing a dedication to global quality benchmarks
  • Additionally, pursued courses geared towards enhancing leadership and management skills for comprehensive professional growth
  • Eagerly seeking to reintegrate into the workforce, bringing a wealth of organizational skills acquired during my career break.

REGULATORY AFFAIRS SPECIALIST

MEDTRONIC INC.
01.2021 - 01.2022
  • Successfully organized and managed a comprehensive document inventory for core dossier preparation, emphasizing meticulous attention to detail
  • Completed regulatory file applications, skillfully navigating submission processes to regulatory bodies in Kenya and Tanzania
  • Conducted thorough global research and analysis of product-related information, showcasing informed decision-making in compliance matters
  • Maintained precise records of all regulatory activities, underscoring a commitment to accuracy and accountability in regulatory documentation
  • Proficient in risk management methodologies, enabling the identification and mitigation of potential regulatory compliance risks
  • Strong communication skills demonstrated through effective interaction with regulatory bodies, fostering positive relationships and facilitating smooth regulatory processes
  • Proactively stayed informed about emerging trends and advancements in the field, highlighting a commitment to adaptability in evolving regulatory landscapes
  • Developed a nuanced understanding of regulatory landscapes in diverse regions, contributing to a well-rounded skill set in navigating international regulatory frameworks.

REGULATORY AFFAIRS and QUALITY ASSURANCE ASSOCIATE

ROCHE LTD.
01.2016 - 01.2021
  • Served as the Single Point of Contact for Roche Kenya Ltd with the Kenya Pharmacy and Poisons Board, establishing a pivotal role in regulatory communications and coordination
  • Secured import licenses, ensuring the timely importation of both commercial and investigational medicines, showcasing proficiency in navigating regulatory processes
  • Demonstrated knowledge of regulatory guidelines in the Sub Saharan region, encompassing individual National Regulatory Authority guidelines in the East African region, GCP guidelines, WHO guidelines for Medicines and Biological Products, ICH guidelines and ISO Standards for Pharmaceuticals, contributing to informed decision-making
  • Successfully forecasted submission/approval timelines, achieving milestones and providing contingency plans when timelines were at risk, showcasing strategic planning and issue resolution skills
  • Led the successful management of a varied product portfolio spanning multiple Sub-Saharan countries, showcasing adept project management skills
  • Achieved a remarkable 100% success rate in overseeing the entire product lifecycle, demonstrating proficiency in strategic planning, execution, and comprehensive data management throughout the project continuum
  • Guided the implementation of the Quality Manual and Quality Policy, conducting routine audits and contributing significantly to a remarkable 85% decrease in non-compliance instances, emphasizing the impact of proactive corrective action implementation
  • This not only solidified compliance but also set the groundwork for improved operational efficiency and enhanced product quality, crucial elements in navigating complex regulatory frameworks
  • Made significant contributions to implementing regulatory compliance initiatives, resulting in an impressive 98% compliance rating
  • Improved the efficiency of quality assurance through smart integration of advanced data management practices, leading to smoother operations, stronger compliance with regulations, and a shift towards making informed decisions based on data
  • Guided the implementation of the Quality Manual and Quality Policy, demonstrating expertise in putting policies into action
  • Conducted regular internal audits with a keen eye for detail, thoroughly examining change control records and addressing nonconformance
  • Showed a strong commitment to implementing corrective actions promptly, resulting in a significant 85% decrease in non-compliance instances
  • Recognized and addressed inefficiencies, streamlined workflows, and introduced automation where possible
  • Resulted in enhanced operational efficiency, minimized compliance risks, and an organization that was more agile and compliant
  • Worked collaboratively with cross-functional teams to successfully execute planned recall and market withdrawal activities, achieving a perfect 100% success rate
  • This underscores effective teamwork and strategic coordination, resulting in a significant impact on product safety and regulatory compliance
  • Conducted targeted training sessions, significantly improving team members' adherence to quality standards by 80%
  • Simultaneously, ensured adherence to ethical standards, resulting in a notable 100% increase in stakeholder trust.

PRODUCT DEVELOPMENT PHARMACIST

UNIVERSAL CORPORATION LIMITED
01.2015 - 01.2016
  • Spearheaded comprehensive drug development studies, demonstrating expertise in scientific research and strategic planning, resulting in optimized processes
  • Led and conducted process validations and controls for formulations during pilot batches, industrial trials, and launches, contributing to streamlined and efficient processes
  • Executed stability and compatibility tests for initial commercial productions, ensuring strict adherence to quality standards
  • Coordinated projects aimed at optimizing processes, effectively enhancing operational efficiency across various stages of product development
  • Analyzed bulk samples and managed deviations, ensuring timely resolution of nonconformities and maintaining high-quality standards
  • Acted as a technical consultant, providing support to processing operators in the efficient handling of bulk materials
  • Ensured plant compliance with ISO and cGMP guidelines, maintaining a commitment to regulatory standards
  • Collaborated with cross-functional teams, aligning with organization strategies and fostering a culture of quality and compliance
  • Conducted risk assessments and collaborated with safety, operations, and quality teams to mitigate production risks
  • Actively participated in safety, quality, and performance initiatives within the organization, contributing to a culture of continuous improvement.

Education

MASTER OF SCIENCE (M.SC.) IN GENERAL HEALTH SCIENCE -

Nelson Mandela University
01.2012

BACHELOR OF PHARMACY (B.PHARM.) IN PHARMACY -

Nelson Mandela University
01.2009

Skills

  • Audit and Inspection Management
  • Database management
  • Documentation
  • Drug Development
  • Ethical and Professional Conduct
  • Project Management
  • Quality Management Systems
  • Regulatory Compliance
  • Risk Management
  • Technical Writing
  • Training and Development

Research and Presentations

  • Completed a postgraduate degree (M.Sc.) focusing on synthesizing Cyclo (D-Phe-2Cl-Pro) and Cyclo (Phe-4F-Pro).
  • Presented at the 4th Biennial Scientific Conference on Medical Products Regulation in Africa (SCoMRA IV) in Zimbabwe.

Software

- ERP - Veeva Vault QMS - SharePoint - Trello - Box - DocuSign - LMS - TrackWise - TeamMateAudit

Professional Society Memberships

  • 2006-2014: South African Pharmacy Council
  • 2015- Present: Pharmacy and Poisons Board, Kenya
  • 2017- Present: Pharmaceutical Society of Kenya

References

References available upon request.

Timeline

Entrepreneurial Venture and Caregiver Break

SELF-EMPLOYED
01.2023 - Current

REGULATORY AFFAIRS SPECIALIST

MEDTRONIC INC.
01.2021 - 01.2022

REGULATORY AFFAIRS and QUALITY ASSURANCE ASSOCIATE

ROCHE LTD.
01.2016 - 01.2021

PRODUCT DEVELOPMENT PHARMACIST

UNIVERSAL CORPORATION LIMITED
01.2015 - 01.2016

MASTER OF SCIENCE (M.SC.) IN GENERAL HEALTH SCIENCE -

Nelson Mandela University

BACHELOR OF PHARMACY (B.PHARM.) IN PHARMACY -

Nelson Mandela University

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