Anita Habibi
Veterinary Clinical Quality Assurance
Kansas City, Kansas
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Summary
Experienced Quality Assurance Manager with a demonstrated history of working in the biotechnology industry. Skilled in Good Laboratory Practice (GLP), Quality Management, Bioanalysis, Clinical Trials, and Toxicology. Strong healthcare services professional with a Bachelor of Art and Science focused in Genetics from University of Kansas.
Experience
2015
Mar
-
2020
Jun
Manager of Quality Assurance and Regulatory Compliance
Kindred Biosciences / Burlingame, CA
- Develop, implement, manage, audit and maintain GCP/GLP quality systems
- Perform quality assurance inspections of study protocols, reports, raw data for veterinary clinical trials according to VICH GL9 Guideline and non-clinical studies according to GLP to assure the integrity of studies and adherence to protocols and SOPs
- Coordinate and perform vendor qualification and compliance audit
- Provide oversight for activities performed by CROs
- Review all deviations in Veterinary Clinical and Target Animal Safety Studies
- Work across all disciplines to maintain state of readiness for inspection by regulatory agency
- Keep abreast of changes to quality regulations and guideline and advising the management team of any business implication of these changes
- Prepare and present training programs in Good Clinical Practice Guidelines for Veterinary trials, and the Good Laboratory Practice regulations
- Lead, manage, ensure proper training of personnel throughout the company
- Provide quality guidance to product development projects and programs
- Represent QA at senior management, project team and other relevant meetings
- Provide audit reports to management team and discuss any major/critical issues that may rise
- Perform quality assurance inspections of study protocols, reports, raw data for veterinary clinical trials according to VICH GL9 Guideline and non-clinical studies according to GLP to assure the integrity of studies and adherence to protocols and SOPs
- Coordinate and perform vendor qualification and compliance audit
- Provide oversight for activities performed by CROs
- Review all deviations in Veterinary Clinical and Target Animal Safety Studies
- Work across all disciplines to maintain state of readiness for inspection by regulatory agency
- Keep abreast of changes to quality regulations and guideline and advising the management team of any business implication of these changes
- Prepare and present training programs in Good Clinical Practice Guidelines for Veterinary trials, and the Good Laboratory Practice regulations
- Lead, manage, ensure proper training of personnel throughout the company
- Provide quality guidance to product development projects and programs
- Represent QA at senior management, project team and other relevant meetings
- Provide audit reports to management team and discuss any major/critical issues that may rise
2008
Jan
-
2014
Mar
Senior Quality Assurance Auditor
QA Compliant / Olathe Kansas
- Responsible for ensuring that all company’s business conforms to applicable Good Laboratory Practices (GLP) including Organisation for Economic CO-Operation and Development (OECD), Environmental Protection Agency (EPA) and Japan Ministry of Health Labour and Welfare (MHLW)
- Ensure each company is compliant with applicable regulations and Standard Operating Procedures (SOP) by auditing protocols, data, reports and conducting experimental phase audits for in-vivo toxicology
- Conducting analytical data, draft and final report as well as bioanalytical and residue analysis GLP based audits.
- Bioanalytical and Analytical method validation
- Communicate audit findings to Study Director and Management
- Prepare QA Statements and maintain accurate records of all inspections
- Review protocols, reports and Standard Operating Procedures
- Training other quality assurance auditors
- Hosting Sponsor visits for client companies
- Hosting EPA visit for client companies
- Provide Intro to GLP Training
- Computer System Validation
- Process based inspections
- Ensure each company is compliant with applicable regulations and Standard Operating Procedures (SOP) by auditing protocols, data, reports and conducting experimental phase audits for in-vivo toxicology
- Conducting analytical data, draft and final report as well as bioanalytical and residue analysis GLP based audits.
- Bioanalytical and Analytical method validation
- Communicate audit findings to Study Director and Management
- Prepare QA Statements and maintain accurate records of all inspections
- Review protocols, reports and Standard Operating Procedures
- Training other quality assurance auditors
- Hosting Sponsor visits for client companies
- Hosting EPA visit for client companies
- Provide Intro to GLP Training
- Computer System Validation
- Process based inspections
Education
1995
-
1999
Kansas University
Bachelor of Art and Science / Genetics
Skills
