S. ABHIRAAMI
Chengalpattu,TAMIL NADU
Summary
Innovative Biotechnologist with 3+ years of experience in working as Quality Control and Quality assurance and regulatory affairs. As an individual contributor, helped Trivitron with timely release of 30+ products, 2 products launches and first one to get license for HbA1c HPLC method in India. Thorough knowledge of GMP & GLP regulations and responsible for production of products, initiating SFG and complete FG within given ETA. Proven records of collaboration with cross- functional teams to achieve continuous improvement and far- reaching objectives. Ability to manage challenging research schedules while working in complex and high- demanding environment. Expertise in many areas of research that utilizes in vivo, ex vivo and in vitro skills. Pragmatic strategist able to focus on key issues and results to meet organizational priorities and make necessary critical decisions to see them through.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Quality assurance and Regulatory Affairs
Trivitron Healthcare Pvt Ltd
03.2024 - Current
- Optimized the licensing workflow for 30+ products, resulting in a 40% reduction in approval time. This enhancement ensured regulatory compliance and accelerated market readiness and sales efficiency by 20%.
- Developing, implementing, and maintaining quality management system QMS (ISO 9001: ISO 13485: ISO 23640: ISO 14971: ISO 18113-2: EN 13612: ISO 15223).
- Responsible for allocation of work to production team for a monthly target of 90 % yield from monthly forecast and plan accordingly for raw material consumption (ETA) for the month.
- Proficient in SAP and Procurement of materials for production.
- Maintained stringent compliance with safety, operational, field, and 5S standards.
- Managed assigned projects to ensure efficient delivery of new traits and technologies through consistent application of project management principles, business analysis and budget/resource planning.
- Ensured project plans capture IP strategy, built-in compliance with product stewardship requirements.
- Involved in R&D and project execution for HPLC, enhance the market with 65% profit for the organization targeting 20+ Lakh profit every month.
- Initiates and co-ordinates laboratory testing, preparation of SOP’s, IFU and other regulatory documents (DHF, DMF, post- market surveillance report, shelf-life study).
- Worked closely with the product manager, production manager and to ensure all monitoring activities are conducted according to study requirements. Positively influenced the meetings, provide MOM and meet deadlines for the given project.
- Resolved and escalated issues in a timely manner.
- Grouped with sales team, marketing team to identify project dependencies and analyze the critical paths.
Executive- Quality Control
Lifecell International Pvt Ltd
Chennai, India
10.2022 - 02.2024
- As a Quality Control executive, developed and maintained the quality, stability, and chemical and physical characteristics of Amnion-Chorion allograft derived from umbilical cord.
- Maintained a safe and productive environment while executing protocols related to Amnion Chorion production.
- Executed assays to characterize in vitro tissues e.g., imaging, histology, wound healing assay.
- Experimented various molecular techniques using different cell cultures e.g., CHO, DF, MG63, SIRC etc.
- Created robust quality control processes, resulting in a significant reduction in product defects and customer complaints. Conducted thorough inspections and audits to identify areas for improvement and implement of CAPA.
- Conducted routine wet-lab work, experimental design, process development, troubleshooting, documentation, and data analysis for biological wound care products.
- Expertise in biochemistry assays e.g., BCA, Bradford assay, ELISA.
- Working experience in cGMP, ISO 17025 regulated environment.
- Utilized data analysis and statistical techniques to identify trends and patterns, enabling quality control measures.
- Effective laboratory management, including SOP development and inventory oversight, ensuring compliance with internal and external audits.
- Extract RNA from in-house tissue samples, which was used to generate cDNA for qPCR and other RNA techniques.
- 95% effective preventing contamination when handling tissue & preparing culture media by practicing sterile technique.
- Eliminated expenses on reagents by 40% through time shortage on incubation without affecting the outcome.
Intern
Biocon Biologic Limited
07.2022 - 10.2022
- Collaborated with various teams to know the workflow of production from upstream to downstream.
- Responsible for performing routine sampling, related to manufacturing of products for commercial in a controlled cleanroom environment.
- Maintained a professional attitude throughout the internship, representing the company in a favorable manner and organized accurate lab notebook and data documentation, BMR for production activities.
- Worked closely with the rapid prototyping team to iterate on bioreactor designs.
- Proper knowledge on PPE in respective work stations.
Education
Bachelor of Technology - Biotechnology with specialization in Genetic engineering
SRM Institute of Science and Technology
06.2022
Skills
- Chromatography
- Protein estimation
- ELISA
- SDS-PAGE
- Western blot
- Dialysis
- Handling of animal models
- Plasmid DNA isolation
- Ligation
- Genomic DNA extraction
- Total RNA extraction
- RT-qPCR
- PCR
- Agarose gel electrophoresis
- Sterile/aseptic technique
- Culturing and sub-culturing adherent and suspension of mammalian cell lines
- Cell counting
- Fluorescent microscopy
- Cell proliferation assay
- Cell culture
- Functional & in vitro assays
- Blast N
- Blast P
- UNIPORT
- PROSITE Tool
- MS Office
- PubMed search
- C
- Python
- R
- SAP
- LIMS usage
- HPLC
- ELISA reader
- Nanodrop
- UV-Spectrometer
- Automated machine
- Semi-automated machine
- Moisture analyzer
- Weighing machine
- Microscope
- Media preparation
- Sterilization
- Steak plate technique
- Autoclaving
- Inoculating
- Serial dilution
- Tittering
- Presentation
- Processing and documentation
- Organizational skills
- Verbal and communication skills
- Attention to details
- Project management
- Literature review
- Scientific writing
- Data visualization
Certification
- Understanding cancer metastasis, Coursera, Johns Hopkins University
- Introduction to the biology of cancer, Coursera, Johns Hopkins University
- Biomedical Nanotechnology, NPTEL, IIT Roorkee, 50%
- Six Sigma White belt, Council for Six Sigma Certification (CSSC)
Personal Information
Title: Quality Control & QARA Specialist
Timeline
Quality assurance and Regulatory Affairs
Trivitron Healthcare Pvt Ltd
03.2024 - Current
Executive- Quality Control
Lifecell International Pvt Ltd
10.2022 - 02.2024
Intern
Biocon Biologic Limited
07.2022 - 10.2022
Bachelor of Technology - Biotechnology with specialization in Genetic engineering
SRM Institute of Science and Technology