Krutika Aashwinikumar Devari
Issaquah,Washington
Summary
Self-motivated, committed, and well-organized Pharmacy Professional with about 27 months (approximately 2.5 years) of experience in Regulatory Affairs, Quality Control performance in sample analysis, regulatory compliance, and documentation. Experienced in reviewing protocols, identifying deficiencies in the protocols or reports, and the ability to work with other cross-functional departments. Analytical Quality Control Analyst offering experience in implementing and monitoring quality control systems. Skilled in interpreting technical data, identifying trends, and ensuring compliance with established standards.
Overview
3
3
years of professional experience
Work History
Quality Control Analyst
Inventprise
Redmond, WA
05.2024 - Current
- Responsible for the entire analytical process, from sample preparation through data analysis, using equipment such as HPLC.
Knowledge of the calibration and operation of the HPLC system with Empower software.
Write and review Standard Operating Procedures for assays and qualifications associated with timelines.
Knowledge of Analytical Method Validation.
Periodically presenting results and summarizing progress to the team members.
Maintaining instrumentation in the laboratory.
Problem-solving skills and the ability to develop plans for the implementation of experiments, and to contribute to the analytical group planning. - Identified quality problems and recommended solutions.
- Completed data capture forms, equipment logbooks or inventory forms to support testing procedures.
- Set and achieved product quality objectives while meeting product specifications.
- Maintained lab cleanliness and safety standards.
- Worked with off-site teams to complete timely tests and facilitate smooth product releases.
- Calibrated, validated or maintained laboratory equipment.
DRUG REGULATORY AFFAIRS TRAINEE, EXECUTIVE – ANALYTICAL DEVELOPMENT LABORATORY
KORES (INDIA) LIMITED
10.2021 - 04.2023
- Filed CEP Dossier (Certification of Suitability to the monographs of the European Pharmacopoeia) for the API, Ambroxol Hydrochloride Ph
- Eur
- According to the eCTD format to European Directorate for Quality of Medicines and Healthcare (EDQM) which certifies regulatory compliance as per the requirements
- Compiled and submitted Drug Master Files (DMFs) for different Active Pharmaceutical Ingredients in domestic and international markets
- Identified how to address issues by reviewing the SOPs (Standard Operating Procedures) of different cross-functional departments and addressing deficiencies with suitable recommendations
- Ensured regulatory compliance with applicable regulations by preparing and reviewing the technical documents required during submission
- Maintained and archived all regulatory documents such as protocols, reports, certificate of analysis, SOPs, etc
- As per the requirement
- Also, adhered to deadlines in submitting the documents requested by the customers
- Developed, conducted and successfully validated methods used for analytical method validation and cleaning method validation using HPLC (High Performance Liquid Chromatography), UV
- Continuously utilized chromatographic knowledge in impurity identification and peak resolutions to determine the impurity present in the drug
- Authored analytical methods, protocols and reports for drug analysis including the impurities, related substances and residual solvents
- Prepared and submitted protocols, reports, Certificate of Analysis (COA), Specification and Method of analysis (MOA) required for compilation of DMFs and CEP Dossier
Education
Master of Science - BIOMEDICAL REGULATORY AFFAIRS
University of Washington
Seattle, WA06-2026
POST GRADUATE DIPLOMA - DRUG REGULATORY AFFAIRS (API & FORMULATION)
INSTITUTE OF PHARMACEUTICAL MANAGEMENT
09.2021
MBA - HOSPITAL AND HEALTHCARE MANAGEMENT & HUMAN RESOURCE MANAGEMENT
MIT WORLD PEACE UNIVERSITY SCHOOL OF MANAGEMENT
04.2020
BACHELOR OF PHARMACY -
NCRDs STERLING INSTITUTE OF PHARMACY
04.2018
Skills
- Handling of analytical instruments (HPLC, UV spectrophotometer, Karl Fischer titrator, auto titrator, pH analyzer, electronic weighing balance)
- Data integrity and laboratory compliance
- GMP documentation: Protocol and report writing
- Quality management systems
- Assay validation
- Testing procedures
- Lab collaboration
- Test coordination
- Team collaboration
- Written and verbal communication
- Document control
- Regulatory compliance
- Result-oriented
Timeline
Quality Control Analyst
Inventprise
05.2024 - Current
DRUG REGULATORY AFFAIRS TRAINEE, EXECUTIVE – ANALYTICAL DEVELOPMENT LABORATORY
KORES (INDIA) LIMITED
10.2021 - 04.2023
Master of Science - BIOMEDICAL REGULATORY AFFAIRS
University of Washington
POST GRADUATE DIPLOMA - DRUG REGULATORY AFFAIRS (API & FORMULATION)
INSTITUTE OF PHARMACEUTICAL MANAGEMENT
MBA - HOSPITAL AND HEALTHCARE MANAGEMENT & HUMAN RESOURCE MANAGEMENT
MIT WORLD PEACE UNIVERSITY SCHOOL OF MANAGEMENT
BACHELOR OF PHARMACY -
NCRDs STERLING INSTITUTE OF PHARMACY