Jamunaa Ravindran Email & Phone Number

Johore, Malaysia

• Review SOPs for Quality Assurance to ensure compliance with cGMP standards and regulatory requirements.• Perform in-process QA activities, including routine checks, line clearance, and online documentation review to monitor manufacturing and packing operations.• Conduct online reviews of batch records and logbooks, ensuring accuracy and adherence to quality standards during production.• Participate in investigations related to QA and production activities, implementing CAPA based on investigation outcomes.• Ensure compliance with procedures on the shop floor, including active involvement in sampling activities and AQL checks for visual inspection.• Monitor and maintain online documentation on the shop floor to ensure real-time compliance.• Support internal and external audits by preparing reports and ensuring follow-up on CAPA and regulatory submissions.• Oversee documentation control processes, including the issuance, archival, and review of batch records.• Collaborate with cross-functional teams across Quality Control, Warehouse, Engineering, and Environmental, Health & Safety to ensure compliance with QA standards and procedures.

Johore, Malaysia

• Completed an 18-week, full-time certification program, delivered by esteemed faculty from Keck Graduate Institute (California, USA) and Biocon Academy.• Engaged in functional visits to Biocon facilities, guided by subject matter experts, with assignments from KGI focusing on Quality, R&D, and Regulatory Affairs.• Underwent a 1-week hands-on training at BiOZEEN, Bengaluru, focused on lab-scale and pilot-scale fermentation, including Clean-In-Place (CIP) and Sterilize-In-Place (SIP) systems.• Led a case study project on drug development, manufacturing processes, quality control, and regulatory aspects.• Completed extensive coursework in:-Pharmaceutical Drug Development-Biopharmaceutical Quality Assurance and Control-Fermentation-Introduction to US Food and Drug Law-Molecular Biotechnology-Mammalian Cell Biotechnology-Bioseparations-Chemistry, Manufacturing & Controls - Regulation of Biologics

Johor Bahru, Johore, Malaysia

• Planned, modified, and executed research protocols related to proteomics and bioinformatics.• Kept a comprehensive record of experiment logs and generated raw data to ensure data integrity and traceability.• Interpreted data, troubleshooted experimental issues, and planned next steps accordingly.• Prepared and reviewed materials for reports, presentations, and manuscripts for journal publications, leading to 1 conference presentation and 1 publication.• Communicated experiment procedures, results, and findings effectively to supervisor.• Assisted undergraduate research students in performing their laboratory work, providing guidance and support as needed.• Communicated with suppliers to restock research materials and chemicals in the laboratory, ensuring continuous availability of essential resources.• Maintained laboratory safety and a sterile working environment to ensure a secure and productive research environment.• Stayed up-to-date with the latest literature and integrated findings into the research work, putting data in context in relation to current scientific knowledge.

Johore, Malaysia

• Retained sample authenticity by receiving and labelling samples accordingly.• Analysed biological samples by performing several routine clinical tests and microscopy analyses.• Preserved accuracy of clinical results and record confidentiality by recording all data and results in specified forms with accuracy and responsibility.• Monitored and reported the results of clinical studies to the laboratory supervisor.• Maintained the reputation of the laboratory by ensuring laboratory equipment hygiene and good working order for optimal functionality and longevity.• Handled specimens according to standard laboratory protocols and procedures to maximize accuracy and precision of results.• Supported the team for general administrative tasks to facilitate smooth laboratory operations.

Master Of Philosophy - Mphil, Biosciences

Biocon Kgi Certificate Program In Biosciences

Course modules: • Pharmaceutical Drug Development • Biopharmaceutical Quality Assurance and Control • Fermentation • Introduction to US.

Bachelor Of Science - Bs, Biology/Biological Sciences, General, First-Class Honours

Dean's Award