Salomi Neerati
Irving,TX
Summary
Quality Assurance Specialist with expertise in developing and revising SOPs to align with current GMP requirements, ensuring operational consistency. Experienced in conducting comprehensive laboratory investigations, including LIRS, OOS, and OOT, to uphold data integrity and maintain product quality. Proven ability to manage change control processes and implement Quality Systems in compliance with 21 CFR 211 and global regulatory standards. Skilled in conducting thorough investigations of product complaints, driving CAPA initiatives, and ensuring continuous compliance with FDA regulations. Adept at managing manufacturing issues, conducting root cause analyses, and presenting findings to support batch release and GMP compliance.
Overview
5
5
years of professional experience
1
1
Certification
Work History
QA Specialist
Mars Therapeutic Private Limited
01.2020 - 05.2022
- Developed and updated Standard Operating Procedures (SOPs) to meet current GMP standards and maintain operational consistency
- Led laboratory investigations, including Laboratory Investigation Reports (LIRS), to identify and address root causes of deviations, ensuring data integrity
- Managed Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, utilizing advanced analytical methods and regulatory expertise to uphold product quality
- Oversaw change control processes, ensuring all procedural updates were thoroughly evaluated, documented, and approved in line with regulatory standards
- Conducted comprehensive product complaint investigations, including root cause analysis and risk assessments, to determine and implement effective corrective and preventive actions (CAPA)
- Implemented corrective and preventive actions to address FDA inspection findings, ensuring ongoing compliance
- Coordinated the collection, handling, and quality testing of product samples
- Managed reportable event investigations and collaborated with Third Party Manufacturers (TPMs) for sample returns and analysis
- Conducted CAPA investigations, driving the implementation of corrective and preventive actions to resolve recurring customer complaints
- Prepared detailed reports on investigation findings, contributing to continuous quality improvement initiatives within the QA department
- Implemented proactive strategies to prevent recurring issues, supporting overall quality improvement efforts
- Utilized word processing software (e.g., MS Word) to create and revise documents such as SOPs, reports, and correspondence
- Participated in internal and external audits to ensure compliance with SOPs and regulatory requirements
- Collaborated with cross-functional teams to manage complaint escalation and resolution, ensuring prompt responses and customer satisfaction
Pharmacist
Satya Sai Medical store
09.2017 - 12.2019
- Ensuring accurate preparation and delivery of prescribed medications to patients
- Providing guidance on the proper use of medications, including potential side effects and interactions
- Monitor patient medication regimens, making recommendations for therapy adjustments based on clinical outcomes and laboratory results
Equipment Handle
Pharma patashala
06.2017 - 08.2017
- Two months training program on pharmaceutical instruments
- Hands on equipment handling like HPLC, UV- VIS Spectroscopy, Karl fisher, Dissolution, Disintegration Apparatus etc
Education
Masters - health informatics
University of North Texas
05.2024
Master’s - Pharmaceutics
Aurobindo College of Pharmaceutical Sciences
01.2017
Bachelors - pharmacy
Aurobindo College of Pharmaceutical Sciences
06.2014
Skills
- Collaboration and communication
- Requirements analysis
- Applications: MS- Office power point,ms excel
- Clinical SAS, python,
- Website development
- Data visualization
- Electronic Health records
Certification
- Certificate for Introduction to Probability and Data with R, Duke University, Coursera
- 12-week Python course in Technical Skill Development solutions
- 12 weeks medical coding training course in sriraetnasolutions, Medical coding training is a specialized educational program designed to teach individuals how to translate medical diagnoses, treatments, and procedures into standardized codes for billing, insurance claims, and health record-keeping purposes.
Timeline
QA Specialist
Mars Therapeutic Private Limited
01.2020 - 05.2022
Pharmacist
Satya Sai Medical store
09.2017 - 12.2019
Equipment Handle
Pharma patashala
06.2017 - 08.2017
Master’s - Pharmaceutics
Aurobindo College of Pharmaceutical Sciences
Bachelors - pharmacy
Aurobindo College of Pharmaceutical Sciences
- Certificate for Introduction to Probability and Data with R, Duke University, Coursera
- 12-week Python course in Technical Skill Development solutions
- 12 weeks medical coding training course in sriraetnasolutions, Medical coding training is a specialized educational program designed to teach individuals how to translate medical diagnoses, treatments, and procedures into standardized codes for billing, insurance claims, and health record-keeping purposes.
Masters - health informatics
University of North Texas
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