02/20/2025 updated
ON
100 % available
Lead Auditor and Pharmaceutical QA Consultant
Derby, United Kingdom
Worldwide
PhD Biogeochemistry, University of Newcastle, UKAuditingAudit ManagementGood Manufacturing PracticesCorrective and Preventive Action (CAPA)ComplianceInformation SystemsData IntegrityProject ManagementMedicines and Healthcare Products Regulatory Agency (MHRA) GuidesPharmaceuticalsQuality ManagementRisk AnalysisTechnical DocumentationPharmaceutical RegulationsSupplier Quality Assurance
GMP/GDP Auditing
Independent GMP/GDP Auditing and Report Writing. Experience in conducting audits across pharmaceutical manufacturing and distribution processes.
Regulatory Compliance
Regulatory Compliance (FDA, EU GMP, MHRA). In-depth knowledge of pharmaceutical regulations and ability to ensure compliance across various regulatory frameworks.
Quality Management Systems
Design and implementation of Quality Management Systems (QMS). Expertise in developing and maintaining comprehensive quality systems in pharmaceutical environments.
Data Integrity
Proficiency in ensuring data integrity in pharmaceutical processes.
Risk Management
Risk Management & CAPA Implementation. Skilled in identifying, assessing, and mitigating risks, as well as implementing corrective and preventive actions.
Technical Documentation
Technical documents preparation and review. Expertise in authoring and reviewing SOPs, quality agreements, and other critical documentation.
Project Management
Project management in pharmaceutical quality assurance. Experience in leading and managing quality-related projects across various pharmaceutical operations.
Independent GMP/GDP Auditing and Report Writing. Experience in conducting audits across pharmaceutical manufacturing and distribution processes.
Regulatory Compliance
Regulatory Compliance (FDA, EU GMP, MHRA). In-depth knowledge of pharmaceutical regulations and ability to ensure compliance across various regulatory frameworks.
Quality Management Systems
Design and implementation of Quality Management Systems (QMS). Expertise in developing and maintaining comprehensive quality systems in pharmaceutical environments.
Data Integrity
Proficiency in ensuring data integrity in pharmaceutical processes.
Risk Management
Risk Management & CAPA Implementation. Skilled in identifying, assessing, and mitigating risks, as well as implementing corrective and preventive actions.
Technical Documentation
Technical documents preparation and review. Expertise in authoring and reviewing SOPs, quality agreements, and other critical documentation.
Project Management
Project management in pharmaceutical quality assurance. Experience in leading and managing quality-related projects across various pharmaceutical operations.
Languages
EnglishNative speaker
Project history
Responsibilities include acting as RP, maintaining QMS oversight, ensuring regulatory compliance, GDP training, supplier quality management, and technical document writing.
Developed audit plans, conducted GMP audits, assessed compliance with EU GMP, GDP, FDA guidelines, prepared audit reports, and evaluated quality management systems.
Conducted data integrity risk assessments, designed compliant supplier management processes, and managed supplier compliance audits.