Aswathy S

About Aswathy S

As a results-oriented microbiology professional with over 3 years of experience in the pharmaceutical and bioscience industries, I specialize in microbiological testing, quality control, and ensuring compliance with stringent GMP and GLP standards. My expertise spans across executing advanced analytical techniques, developing and implementing SOPs, conducting environmental monitoring, and maintaining data integrity to drive operational excellence. In my current role as Senior Officer – QC Microbiology at Apotex Research, I lead initiatives to improve quality control processes, reduce deviations through effective CAPA implementation, and ensure seamless regulatory compliance. Previously, as a Scientist – Microbiology at Anthem Bioscience, I contributed to preclinical research, supported genotoxicity testing, and streamlined laboratory operations, enhancing team performance and data accuracy. Key highlights of my career include: • Developing and revising over 20 SOPs to align laboratory procedures with regulatory standards. • Successfully implementing CAPA processes, reducing deviations by 20%. • Establishing environmental monitoring programs to maintain compliance with preclinical and GLP standards. With a Master’s degree in Microbiology and certifications in credential evaluation, I bring a strong academic foundation coupled with hands-on expertise in microbiological analysis, regulatory compliance, and operational leadership. Passionate about continuous improvement, I thrive on solving complex challenges and collaborating across teams to achieve organizational goals. Let’s connect to discuss opportunities in microbiology, quality assurance, and regulatory compliance.

Experience

1. Senior Officer

   Apotex Inc.

   Apr 2024 — Present · Bengaluru, IN

   Conducted microbiological quality control testing on pharmaceutical products compliant with GMP regulations.• Developed and implemented corrective and preventive actions (CAPA) to address deviations and improve processes by 30%.• Authored and revised standard operating procedures (SOPs) to ensure 100% regulatory compliance.• Monitored environmental conditions, including water and material analysis, to maintain sterility standards.• Ensured data integrity and compliance with ALCOA+ principles across laboratory operations.• Coordinated with cross-functional teams to facilitate audits and ensure compliance with regulatory bodies.• Led investigations into deviations and identified root causes to develop and execute preventive measures.

Education

• Mahatma Gandhi University

  Bachelor of Science in Microbiology

  2015 — 2018

• The Oxford College of Science, HSR layout Bangalore

  Master's degree

  2018 — 2020