Anitha H P

Dynamic Senior Quality Assurance Manager with extensive experience at Emmes India, excelling in regulatory compliance and risk assessment. Proven track record in driving process improvements and managing audits, while fostering collaborative team environments. Adept at data analysis, ensuring quality standards are met, and enhancing operational efficiency.

• Prepare and review documentation under QA purview for accuracy and compliance.
• Conduct Internal/supplier/vendor qualification and evaluation Audit.
• Host external/client audits.
• Prepare Quality Management Reports for Management Review.
• Serve as back-up to Corporate QA Head in corporate meetings or location specific meetings.
• Ensure clinical trials/study are performed in accordance with applicable protocol and in compliance with GCP guidelines.
• Writing and reviewing Clinical SOPs and other quality documents.
• Vendor/supplier qualification in coordination with cross-functional departments.
• Lead internal auditor for ISO 9001:2008 audit, identification of non-conformances, root cause analysis and suggesting appropriate CAPA for the closure of audit points.
• Conducting Quality management review meeting to reach the organization goals in compliance with current regulatory requirements.
• Ensure that all processes contributing to the performance of a clinical trial are conducted properly.
• Point of contact for quality at all India Clinical sites.
• Collaborate with Corporate QA in managing Quality Management System.
• Conduct training, as needed for QA and other departments.
• Conduct internal audit of projects and departments as IQAT.
• SOPs and policies Management.
• Prepare and assist in preparing annual reports and quality trending reports.
• Report the status of the quality levels of staff, systems and production activities.
• Keep up to date with all related quality legislation and compliance issues.
• Ensure regulatory rules are communicated through corporate policies and procedures.
• Ensure that investigator, vendor, facility and system audits are conducted.
• Communicate any critical compliance risks noted from these activities to senior management.
• Conduct of eTMF Audits for project in scope, training on the eTMF tool and management of document mapping in TMF structure for projects not in eTMF.
• Leading and conducting GCP audits of Clinical investigator Sites to assess compliance with study protocol, applicable regulations, guidelines policies, procedures and sponsor requirements.
• Preparing and executing risk-based investigator site audit plans, supporting scheduling and reporting of CI site audits.
• Providing support for GCP regulatory authority inspections of sponsor, clinical investigator sites and external service providers, where applicable.
• Providing GCP guidance to clinical study teams, evaluating and processing potential quality issues, escalations and potential serious breaches.
• Plan, organize and lead audits of clinical investigator sites for compliance to protocols, policies, SOPs, and applicable regulations.

22, 8, 14

• Senior Quality Assurance Manager, Emmes India, 11/01/17 to 06/30/23, Sr. Director QA
• Quality Assurance Lead-Pfizer Projects, Bioclinica safety and Regulatory Services, 10/01/16 to 11/01/17, Associate Director
• Quality Assurance Auditor & Assistant Manager Medical Data Review, Quintiles, 03/01/14 to 09/30/16, Associate Director
• Senior Quality Assurance Associate & Quality Assurance Associate, Ecron Acunova, 11/01/12 to 03/31/14, Head QA
• Executive QA & Ethics Committee Coordinator, Triesta Clinical Research. A unit of HCG, 01/01/10 to 11/30/12, Manager QA & Managing Director
• Clinical Research Coordinator, St. Johns Medical College & Hospital (IPHCR), 06/01/08 to 12/31/09, Medical Superintendent
• Duty Doctor, S K Hospital, Horizon Hospital & Vijayanagar Hospital, 07/01/01 to 06/30/08, Managing Director

• Workshop on the Cold-Chain supply management, World Courier, Bangalore, 12/01/11
• Workshop of Ethics Committee Stakeholders, St. John’s Hospital, Bangalore, 12/01/10
• Seminar on NABH requirement and implementation, HCG, Bengaluru, 12/01/11
• Investigator Meeting attended for Phase 2B study in Singapore for Respiratory Diseases trial-SAKURA Study, 12/01/09
• Training in ICH GCP, AstraZeneca and NIH, 12/01/XX
• Training in OHRP and FWA, 12/01/XX
• Training in ISO 9001:2008 and 27001:2005, 12/01/XX
• Abstract/presentation on Clinical data validation, M-Power Institute of Clinical Research, Bengaluru, 12/01/07
• Certified course in C+ and Java, Bangalore, 12/01/04

• English
• Hindi
• Kannada

Will be furnished as required.

Rotarian with spear thoughts on service President Elect 2025 and DEI Chairman for club. Sampling plantation for green eco system development. Coordination with school of special kids for sports day celebration. Active participant in NSS and medical camp in Yelahanka and awarded for good service. Active member of Rotaract Vijayanagar as PRO - 1998. Organized blood donation camp, drawing competition for mentally challenged kids in collaboration with Social Clubs and Hospitals. Participation in the vaccination program for Polio eradication as part of the National Health Program. Organized camps to educate/train/create awareness on burnt injury and strengths of Mentally Challenged Children in Gayathri Hospital.

• Clinical Research Operations
• Quality Assurance
• Pharmacovigilance
• Data Management
• Study Site Operations
• Ethics Committee
• Auditing
• QMS implementation
• RCA
• CAPA
• Metrics
• Trending
• Risk Assessment

• Number of Children: 2
• Date of Birth: 07/28/XX
• Marital Status: Married