Open to opportunities

Sirisha Mallela

@sirishamallela

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Experienced Quality Assurance professional in bio-analytical research.

Zimbabwe

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What I'm looking for

I seek a role in a dynamic organization that values quality and innovation, offering opportunities for growth.

I am a dedicated professional with over 8 years of experience in the field of bio-analytical quality assurance and clinical research. My career has been focused on managing IQM activities and ensuring compliance with regulatory standards in various organizations. Currently, I work as an IQC Associate at Jeevan Scientific Technologies, where I oversee the quality control processes in bio-analytical studies.

Throughout my career, I have been responsible for addressing sponsor and regulatory queries, conducting thorough reviews of standard operating procedures, and ensuring adherence to Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) guidelines. My experience includes managing audits, such as the USFDA virtual audit at Vimta Labs, and I have a proven track record of maintaining high standards of quality in all aspects of bio-analytical research.

I am passionate about continuous learning and adapting to new technologies, which I believe is essential in the ever-evolving field of biotechnology. My goal is to contribute to a progressive organization that values quality and innovation, while also providing opportunities for personal and professional growth.

Experience

Work history, roles, and key accomplishments

Current

IQC Associate

Current

Jeevan Scientific Technologies Limited

Apr 2022 - Present (3 years 2 months)

Currently working as an IQC Associate in the Bio-analytical Department, focusing on managing IQM activities, ensuring adherence to SOPs, and handling sponsor and regulatory queries. Responsible for reviewing study documents, method validation reports, and ensuring compliance with GCP/GLP guidelines.

Quality Assurance Regulatory Compliance Analytical Methods Validation Data Analysis Project Management Communication Documentation Auditing Team Collaboration

Senior Executive

Vimta Laboratories Limited

Jun 2021 - Apr 2022 (10 months)

Served as a Senior Executive in the Bio-analytical Department, managing quality control activities, responding to sponsor queries, and conducting audits. Involved in the review of study documents and ensuring compliance with regulatory standards.

Quality Control Regulatory Affairs Auditing Communication Team Management Documentation Bioanalytical Studies Project Coordination

Senior Executive

Aizant Drug Research and Solutions

Dec 2015 - Jun 2021 (5 years 6 months)

Worked as a Senior Executive in the Bio-analytical Department, focusing on quality assurance and compliance. Responsible for reviewing analytical reports, method validation, and ensuring adherence to GLP guidelines.

Quality Assurance Analytical Methods Validation Regulatory Compliance Documentation Team Collaboration Auditing