Rajvee Vyas
Scranton,Pa
Summary
Experienced Quality Assurance Specialist in the health care Industry with demonstrated track record of improving products and procedures by leveraging hands-on inspections, testing methods and data analysis with strong Engineering background.
Overview
9
9
years of professional experience
Work History
QA Specialist - Investigations
Lupin Pharmaceuticals Inc.
03.2023 - Current
- Assist in investigating and correcting quality-related issues (including customer complaints) through collaboration with other departments.
- Writes, reviews, evaluates Deviations, Incidents, CAPAs, Complaints and Change Controls.
- Assist in the coordination of testing results involving finished products, raw materials, and packaging components and the appropriate release and hold programs associated with these materials.
- Developed supply chain program for international shipments.
- Assist in the implementation of policies, operating procedures, quality systems and programs which ensure proper testing, evaluation, inspection, and technical support to meet product quality standards.
- Oversee the “On Hold” product program, including the status, release, and destruction of “Rejected” products.
- Reviews and approves Engineering Validation Protocols for Equipment’s, Facility, Temperature Mapping and Purified Water system.
- Oversight and approval of SOPs and controlled documents.
- Reviews, maintains, and provides Quality metrics monthly to management.
- Experienced of working on different Quality software, SAP, Track wise, and caliber.
- Performed cleaning validation swab sampling of API & CIP for blending, compression, coating and check weigher equipment for Drug Residue, Detergent Residue, and Microbial Testing
- Collaborated with management to provide training on improved processes and assisted with creation and maintenance of quality training.
Quality Assurance Specialist/ FD/PD
Appco Pharma LLC
03.2020 - 12.2020
- Reviews and approves Engineering Validation Protocols for Equipment’s, Facility, Temperature Mapping and Purified Water system.
- Oversight and approval of SOPs and controlled documents.
- Reviews, maintains, and provides Quality metrics monthly to management. Performed in process inspection for compression, encapsulation, coating and packaging process as defined by the MBRs.
- Experienced in SAP transactions for material release and material dispositions.
- Performed cleaning validation swab sampling for blending, compression, coating and check weigher equipment for drug residue, Detergent residue and Microbial testing.
- Performed AQL sample for blending, Compression and capsules for 100% check weigher.
- Completion of other essential documentation activities like revision of SOPs, batch records and other product related documentation
- Reviewed technical documents such as Batch Records, Protocols and Reports, and Standard Testing Procedures
- Reviewed Investigations, Deviations, CAPA and change control.
Customer Service Lead
Walmart
01.2019 - 01.2020
- Coached new team members on service techniques and provided scoring through quality assurance program.
- Stepped up to assist customer service manager with complaints and issues during times of department short staffing.
- Resolved concerns with products or services to help with retention and drive sales.
- Promoted to team lead of customer service for displaying outstanding enthusiasm and remaining calm in extremely trying situations.
- Responded to customer calls and emails to answer questions about products and services.
- Supervised day-to-day customer service operations to provide staff with guidance and drive productivity.
Graduate Research Assistant
Marywood University
08.2016 - 08.2018
- Researched information regarding HRIS system to assist professors with academic pursuits.
- Helped team meet regulatory requirements by coordinating documentation and filings.
- Completed administrative and research duties per professor request.
Quality Assurance Specialist
Process Technologies And Packaging
01.2015 - 03.2016
- Perform Line Clearances, equipment releases and AQL inspection. Raw material releases, Executed Production Batch Record (PBR) review.
- Performed QA Shop floor activities, including material disposition, material storage and handling requirements, deviations, change control and CAPA management.
- Submission of samples for testing and correction of documents for any ratifications
- Completion of other essential documentation activities like revision of SOPs, batch records and other product related documentation
- Working under strict cGMP regulations and responsible for approving line clearances for manufacturing and packaging operations
Education
MBA - Business Administration And Management
Marywood University
PABachelor of Science - Electrical Engineering
SIT
Skills
- Change control
- CAPA Management
- AQL Inspection
- Batch record review
- SAP
- Investigation
- CGMP
- Equipment calibration/PM
- API/CIP Swab
- Reviewing Investigation
- Material Disposition
- ISO 9001
- Root Cause Analysis
- Compliance requirements
- Audit process management
- Continuous Improvement
- Standards Compliance
- Project management
- Report preparation
- Complaint resolution
Accomplishments
2021 Top Performer Award for Clean hold studies (Lupin Pharmaceutical )
- In recognition for consistently exceeding target in completion of clean hold time studies.
Timeline
QA Specialist - Investigations
Lupin Pharmaceuticals Inc.
03.2023 - Current
Quality Assurance Specialist/ FD/PD
Appco Pharma LLC
03.2020 - 12.2020
Customer Service Lead
Walmart
01.2019 - 01.2020
Graduate Research Assistant
Marywood University
08.2016 - 08.2018
Quality Assurance Specialist
Process Technologies And Packaging
01.2015 - 03.2016
MBA - Business Administration And Management
Marywood University
Bachelor of Science - Electrical Engineering
SIT
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