priyanka edulakanti
Grand rapids,Michigan
Summary
Experienced Validation Engineer skilled in evaluating software systems to align with specifications and project objectives. Meticulous in documentation and reporting for accurate recordkeeping. Enthusiastic and detail-oriented professional committed to effective analysis of test results.
Overview
9
9
years of professional experience
Work History
Computer System Validation Engineer
Grand River Aseptic Manufacturing Inc.
12.2023 - 10.2024
- Mentored junior engineers in best practices for validation engineering methodologies improving team skillsets.
- Established strong working relationships with vendors ensuring smooth communication during project deployment.
- Conducted root cause analysis on deviations during validation activities, enabling timely resolution of technical issues.
- Reduced operational risks associated with validated systems through periodic review assessments and targeted revalidation's when necessary.
- Collaborated with cross-functional teams to resolve complex issues, resulting in reduced downtime and increased production output.
- Improved validation processes by developing and implementing risk-based strategies for equipment, systems, and facilities.
- Documented entire validation process, noting changes or alterations completed.
- Collaborated on Standard Operating Procedure (SOP) development, incorporating input from [Type] team to reduce liability and enhance successful deployments.
- Evaluated change control requests to assess potential impacts on validated systems, ensuring ongoing compliance with regulations.
- Streamlined the revalidation process by identifying opportunities for consolidation or elimination where appropriate.
- Provided technical expertise during the design phase of new equipment installation projects increasing efficiency.
- Developed comprehensive validation master plans to ensure alignment across all projects and stakeholders.
- Trained and assisted staff in validation techniques, methods and testing processes.
- Ensured regulatory compliance with FDA guidelines by conducting thorough validations and maintaining accurate documentation.
- Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity, and other factors.
- Managed and inspected instruments and equipment for manufacturing.
- Analyzed pre-release software titles for compliance with User Requirement Specifications (URS), referring any deficits to appropriate personnel.
Pharma Benefit Analyst
Optum Global Solutions
07.2017 - 08.2019
- Processing various queues of HDP department in Optum RX
- Utilized strong interpersonal and communications skills to serve customers; received employee of month award twice
- Resolved customer concerns efficiently and expeditiously
- Achieved 100 percent of call performance goals for accuracy, speed, volume, resolution of issues, and customer satisfaction
- Nominated for employee-of-month four times for excellent attitude and exemplary customer service skills
Research Associate
Excelra Knowledge Solutions
03.2016 - 11.2016
- Has worked in Formulations department in which I have to map the forms in the preparation of pharmaceutical formulations like topical, parental formulations
- Have to research through the paper to find out the forms for the preparations and map them appropriately
Junior Research Associate
Madhees Consulting Services
08.2015 - 01.2016
- Mapping the reactions from transcript files and capture the data with the help of supporting PDF files
- Documentation on the reactions by doing research activities
- Have done team handling functions, like allocating the requests to other team members; assist them in their doubtful queries, escalating requests to the complaints and compliance department if needed
- Have done Quality checks for the team members, if errors found have done a root cause analysis
- Have given feedback to the team members on their quality, productivity, AHT and maintained SLA's and have initiated and established smooth flow of project, by effectively managing resources, in the absence of my Team Leader lead way for my understanding and knowledge on various reports
Education
Master - Health Informatics
University of Denver
02.2022
Bachelor - Pharmacy
Jawaharlal Nehru Technological University
01.2015
Skills
- Ability to Work Under Pressure
- Testing protocols
- CAPA Management
- Equipment Qualification
- Quality Management Systems
- Validation Protocols
- Data Integrity
- Regulatory guidelines
- Process Validation
- Test method validation
- FDA regulations
- Computer system validation
- GMP compliance
- Effective Communication
Accomplishments
- Achieved 100% results by completing validation tasks with accuracy and efficiency.
- Collaborated with team of 7 in the development of a Project.
- Resolved product issue through consumer testing.
- Used Microsoft Excel to develop inventory tracking spreadsheets.
Languages
English
Native or Bilingual
Timeline
Computer System Validation Engineer
Grand River Aseptic Manufacturing Inc.
12.2023 - 10.2024
Pharma Benefit Analyst
Optum Global Solutions
07.2017 - 08.2019
Research Associate
Excelra Knowledge Solutions
03.2016 - 11.2016
Junior Research Associate
Madhees Consulting Services
08.2015 - 01.2016
Bachelor - Pharmacy
Jawaharlal Nehru Technological University
Master - Health Informatics
University of Denver
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