Hire Gertrude Owusu-Ansah, a pharma consultant specializing in Clinical Studies, Medical Devices and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: Mexico
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Gertrude Owusu-Ansah is an experienced pharmacist and pharmaceutical regulatory professional with over 12 years of experience across pharmaceutical manufacturing, quality assurance, GMP inspection, regulatory affairs, and product registration. Her expertise includes CTD dossier evaluation, variation applications, product information review, API and excipient certification, GMP and GDP inspections, CAPA, change control, supplier audits, and quality-system compliance. She has worked in pharmaceutical manufacturing as a Senior Production Pharmacist and later moved into regulatory roles involving inspections, dossier assessment, and pharmaceutical quality evaluation. Her experience also includes assessing API Drug Master Files, APIMFs, Certificates of Suitability, and excipient master files, as well as supporting quality and regulatory systems aligned with WHO requirements. Her combined manufacturing and regulatory background enables her to support pharmaceutical organizations with quality, compliance, regulatory documentation, and audit-related activities. - Show More
Gertrude supports CAPA activities through her experience managing deviations, investigating root causes, implementing corrective actions, and ensuring closure of recommended actions. She has also contributed to the development of CAPA review and response approaches within a regulatory environment. Her experience can help organizations develop evidence-based corrective and preventive actions that address underlying quality issues and reduce the likelihood of recurrence.
Gertrude has experience reviewing and managing pharmaceutical change controls within manufacturing operations. Her background includes evaluating proposed changes, considering quality and compliance implications, coordinating implementation activities, and monitoring associated actions. She can support organizations in maintaining structured change-management processes that protect product quality, documentation integrity, and continued regulatory compliance.
Gertrude provides support for the investigation and management of pharmaceutical deviations. Her experience includes root-cause investigation, risk assessment, documentation review, CAPA development, and monitoring the implementation of corrective actions. Her combined quality and regulatory perspective enables her to help organizations strengthen deviation investigations, improve technical documentation, and develop appropriate actions to prevent recurrence.
Gertrude has extensive experience conducting GMP inspections and audits of pharmaceutical and herbal manufacturing facilities. Her regulatory inspection background includes assessment of manufacturing operations, documentation, quality systems, and compliance with applicable WHO GMP requirements. Combined with her previous pharmaceutical manufacturing experience, she can support organizations with GMP audits, identification of compliance deficiencies, and practical recommendations for strengthening audit and inspection readiness.
Gertrude supports pharmaceutical organizations with GMP compliance based on her experience in manufacturing, quality assurance, and regulatory inspection. She has evaluated manufacturing facilities against GMP requirements, reviewed production documentation and quality systems, and provided compliance-related guidance and training. Her experience enables her to help organizations identify GMP gaps, improve manufacturing and quality practices, and strengthen overall regulatory preparedness.
Gertrude provides GMP training support drawing on her experience delivering quality assurance and cGMP training within the pharmaceutical sector. Her combined manufacturing and regulatory background allows her to translate GMP requirements into practical guidance for operational teams. She can support organizations with training focused on GMP principles, documentation practices, quality-system requirements, compliance awareness, and inspection preparedness.
Gertrude has practical quality assurance experience across both pharmaceutical manufacturing and regulatory environments. Her responsibilities have included reviewing SOPs, production documentation, risk assessments, deviations, CAPA activities, change controls, and quality-system requirements. She can support pharmaceutical organizations in strengthening quality oversight, improving documentation practices, and maintaining consistent compliance across manufacturing and regulatory activities.
Gertrude has experience working with pharmaceutical Quality Management Systems from both manufacturing and regulatory perspectives. Her background covers quality assurance, SOPs, CAPA, deviations, change control, risk assessment, internal audits, GMP inspections, and implementation of regulatory quality requirements. She can support organizations in evaluating QMS effectiveness, identifying compliance gaps, and strengthening quality processes to support consistent pharmaceutical operations and regulatory readiness.
Gertrude supports pharmaceutical regulatory filing activities through her experience in CTD dossier assessment, product registration, variation applications, and review of supporting regulatory documentation. Her work includes evaluating pharmaceutical quality information, product information, Drug Master Files, APIMFs, Certificates of Suitability, and excipient master files. This experience enables her to support organizations in reviewing regulatory documentation, identifying submission gaps, and improving the quality and completeness of regulatory filing packages.
