Anusha Gutta

Seek a dynamic position in Quality Assurance at a leading pharmaceutical company, utilizing over ten years of experience and specialized knowledge to drive organizational success and improve operational processes.

Bring more than ten years of extensive experience in the pharmaceutical industry, focusing on Quality Assurance and consistently achieving compliance with regulatory standards while improving product quality. Function as a Senior Executive in the Quality Assurance Department at Biological E. Ltd., managing essential quality management processes and guaranteeing compliance with all regulatory standards. Cultivated a diverse skill set that includes vendor qualifications, quality management systems and audit compliance, while actively expanding knowledge of industry best practices and regulatory frameworks. Realized substantial enhancements in quality management processes, resulting in a decrease in non-compliance incidents in the current position, which significantly improved overall operational efficiency. Exhibit strong leadership skills by promoting a collaborative team atmosphere and guiding junior staff to maintain quality standards and drive ongoing improvements. Maintain extensive knowledge of Good Manufacturing Practices (GMP) and Quality Management Systems (QMS), enabling the successful application of quality assurance protocols across multiple projects. Possess comprehensive knowledge of regulatory compliance requirements, such as USFDA and WHO standards, guaranteeing that all quality assurance activities are in line with global best practices.

• USFDA
• ANVISA
• Poland (EMA)
• WHO Geneva
• Novartis
• Blue Point
• Sun pharma
• CDSCO
• Sterimax
• Zentiva

· Quality Management Systems (QMS)

· Market Complaints

· Process Improvement

· Risk Assessment Frameworks

· Audit Management Systems

· Training & Development Programs

· Cross-Functional Collaboration

· Performance Metrics Analysis

· Good Manufacturing Practices (GMP)

· Vendor Qualification Processes

· CAPA Management

· Regulatory Compliance Documentation

· QMS Software Solutions

Overseeing the comprehensive management of Quality Management System (QMS) elements, including Change Controls, Deviations, and CAPA reviews, ensuring meticulous evaluation, approval, and closure of all QMS elements through software solutions., Preparing and analyzing trends for QMS elements and technical investigations, providing actionable insights to the senior management for informed decision-making., Developing and reviewing standard operating procedures (SOP’s) to ensure alignment with industry regulations and internal quality standards., Preparing monthly Quality Metrics to ensure timely submission and adherence to quality standards., Review of Audit Trail Reports monthly for Software QMS Elements., Prepared and presented monthly quality management review presentations to senior management, highlighting key performance indicators and areas for improvement., Collaborated with cross-functional teams to ensure the timely submission of regulatory documents, maintaining a high level of accuracy and compliance., Notifying and Supporting the QMS elements to the Stake holders to meet their regulatory requirements., Leading the preparation of audit plans and conducting internal audits in accordance with in-house SOP's, ensuring compliance with regulatory requirements and closing CAPA for self-inspections., Actively supporting internal and external audits by collecting and presenting necessary process data and compliance reports, facilitating a smooth audit process., Managing market complaints by preparing detailed investigation reports that identify root causes by using the RCA methodologies like fishbone diagrams, 5 Whys, fault tree analysis etc., and recommend appropriate corrective actions., Ensure the implementation of CAPA and Closure of Market Complaints within the Timelines., Resolving the Customer Complaints promptly and Efficiently., Preparation of Market Complaints Trends., Preparation of vendor audit schedule and Supported the vendor qualification process by reviewing vendor documentation and coordinating audits as necessary., Evaluating potential vendors through comprehensive audits, verifying certifications, processes, and track records to ensure they meet the necessary quality and regulatory standards., Coordinating vendor change notifications and maintaining an updated Approved Vendor List, ensuring compliance with regulatory standards and enhancing supplier performance., Developed and implemented Training plans for employees on cGMP and quality assurance procedures, fostering a culture of quality within the organization., Engaged in training programs for new employees on quality assurance processes and procedures, fostering a culture of quality within the organization., Actively participated in the preparation of annual product quality review (APQR) reports, providing graphical presentations of trends and performance metrics., Reviewed batch manufacturing and packing records to ensure compliance with established quality standards and regulatory requirements., Participated in the preparation of stability protocols and reports, ensuring that all documentation met the required quality standards., Review of Summary Protocols and Co-ordination with user departments in sending samples to CDL, Kasaouli.