Sai Rishita Patibandla
Clarksville
Summary
Extensive experience as Deviation Specialist in resolving customer complaints, acting as a liaison with QA, Product Analysis, Sales, and other groups necessary to satisfy customer requests and product complaints. Compiled customer specific complaint data as needed and generated trends as needed. Responsible for implementation of process assurances, process controls, and CAPA systems designed to meet/exceed internal and external requirements. Experienced in ensuring quality standards within aseptic manufacturing through ensuring equipment calibration accuracy and proactive investigation of out-of-tolerance (OOT) deviations, ensuring compliance with regulatory requirements and optimizing operational efficiency within pharmaceutical industry .
Overview
3
3
years of professional experience
4045
4045
years of post-secondary education
Work History
MTO Specialist-II
Catalent Pharma Solutions
Baltimore
05.2024 - Current
- Led manufacturing investigations and utilized root cause analysis tools to find the root cause and contributing factors
- Identifying event impact and communicating/presenting to Manufacturing and Quality
- Defining and supporting corrective and preventative actions (CAPAs) in alignment with Manufacturing requirements .Expertise in Trackwise to route the deviations, change control, perform query and review the reference deviation records.
- Solved manufacturing issues and continuous improvement in process operations
- Wrote, reviewed, and edited cGMP documents and processed through a workflow for the creation of quality-approved documentation
- Collaboration with document control and other Cross-functional supporting groups
- Supported manufacturing internal and external observations
- Practiced and promoted safe work habits while adhering to safety procedures and guidelines
- Developed consistent manufacturing quality standards for Deviations and CAPAs in Quality Systems
- Conducted complex document revisions and management, including batch production records and manufacturing procedures
- Maintained tracking systems for manufacturing compliance priorities
- Worked collaboratively with others to meet group and organizational goals
- Participated in initiatives to support innovation and continuous improvement activities
- Participated in client and planning meetings.
Quality Compliance Specialist
Catalent Pharma Solutions
Bloomington
12.2022 - 04.2024
- Supported in implementing CAPA plans to address identified issues and prevent recurrence of complaint
events. - Reviewed site investigations and complaint records for technical and quality aspects to ensure complaint response is completed as per defined requirements and customer expectations
- Provided a documented report that clearly outlines the investigation process, investigation findings, frequency of related events, corrective actions, and recommendations
- Supported Risk Management and CAPA through customer complaints / root cause investigations and trending analysis
- Ensured proper documentation, investigation, and closure of each complaint in accordance to established procedures
- Responsible for product investigation of post market device complaints in compliance with regulatory guidelines
- Provided Root cause to deviations and CAPAs to ensure non recurrence of the same problem in future
- Supported several validation projects and led validation efforts for various systems like Manufacturing Execution System, ERP Integration and Statistical Process Control (SPC) System to ensure delivery to project schedule
- Involved in root cause analysis activities using Six Sigma methodologies for customer complaints during post market surveillance
- Maintained and update deviation with appropriate status prior to closure of the project for filing
- Worked with QA group to meet target customer satisfaction goals of reduced turnaround time and number of repeat complaints
- Performed weekly, monthly, and customer specific data trending and compile complaint data tables and/or graphs as required
- Implemented 21 CFR Part 11 for deviation draft and define resolutions in compliance with cGMP requirements
- Identified the risk and perform risk analysis program to include Hazardous situation, Risk identification, risk preventive techniques, contract review, patient safety and measuring of effectiveness of Risk management program.
Education
Masters of Science Biomedical Engineering -
University of North Texas
Denton, TexasBachelor of Technology - Biotechnology
KL University
VijayawadaSkills
- Master control
- Blue mountain RAM
- CAPA
- Deviation Management
- Impact assessment
- Root cause Analysis (RCA)
- cGMP
- Good Documentation practices
- Batch record Review
Timeline
MTO Specialist-II
Catalent Pharma Solutions
05.2024 - Current
Quality Compliance Specialist
Catalent Pharma Solutions
12.2022 - 04.2024
Masters of Science Biomedical Engineering -
University of North Texas
Bachelor of Technology - Biotechnology
KL University