Vamshi Goparapu
Rensselaer,NY
Summary
Adept Validation Specialist with a proven track record by showcasing expertise in temperature mapping and exceptional proficiency in technical documentation. Demonstrated ability to enhance manufacturing operations through rigorous audit preparation and equipment calibration, complemented by a strong foundation in SOPs and IQ/OQ/PQ protocols. Renowned for meticulous root cause analysis and a commitment to quality, ensuring regulatory compliance and operational excellence.
Overview
12
12
years of professional experience
Work History
Validation Specialist Consultant
Regeneron Pharmaceuticals Inc
07.2021 - Current
- Drafting and executing IQ/OQ/PQ protocols, Continue Qualification Protocols, Re-Qualification Protocols for various control temperature units like Refrigerators, CO2 Incubators and Ultra-Low Freezers, Coolers, Walk-Ins, Warehouses, Storage rooms, Autoclaves.
- Involved in documentation of different stages of validation life cycle in compliance with 21 CFR part 11.
- Proficient in programming of Kaye Validator, giving set points, calibrating Thermocouples used in the temperature mapping for the qualification of the equipments.
- Proficient in temperature mapping using Ellab data loggers, Valprobes.
- Experience in scheduling and performing executions.
- Performing Risk Analysis and Drafting risk assessment reports.
- Drafted summary reports for the qualification activities conducted on the controlled temperature units.
- Drafted Validation Plans.
- Documented the deviations/issues found during the protocol execution using discrepancies.
- Responsible for training the new hires.
- Experience in Reviewing technical documents, protocols, summary reports, executions.
- Experience in performing electronic executions by using Valgenesis software.
QA Validation
Ascent Pharmaceuticals
03.2018 - 07.2021
- Responsible for providing technical support to operations in terms of equipment/system initial validation and re-qualification’s (Manufacturing Equipment, Packaging Equipment, Walk-in and Standalone Chambers, Tanks, Stability Chambers, Warehouse etc.).
- Develop validation and qualification protocols and reports for the Facility, Manufacturing Processes, Manufacturing Equipment, Packaging Equipment, Packaging Processes.
- Involved in compliance review and coordination of vendor protocols for protocol generation, execution, and summary of various pieces of new equipment.
- Performed temperature mapping for warehouse, stability chambers, manufacturing rooms.
- Coordinate activities of outside validation contractors to ensure validation projects are completed on time and in compliance with Ascent and regulatory standards.
- Experience in Preparation and Review of Batch Manufacturing Record (BMR), Batch Packaging Record (BPR), Process Validation protocol and report, Cleaning Validation protocol and manufacturing failure investigations, OSS investigations, change controls and deviations.
- Coordinate the timing of the cleaning and swab sampling activities with the appropriate Operations, QA and Laboratory personnel. Monitor the cleaning/swab sampling operation to ensure conformance with approved protocols and procedures.
- Schedule and execute equipment re-qualification’s per Standard Operating Procedures (SOPs). Coordinate and communicate all testing with affected functional groups and evaluate test results.
- Experience in assisting management during FDA inspections by providing necessary documents.
- Provide hands on support to the manufacturing areas as required to assist in problem solving and long-term changes that provide product/process improvements in relation to equipment failures.
- Planning and Execution of Pre-validation & Validation & Commercial batches of site transfer projects of oral solid dosage forms.
- Performed in-process samplings at different stages like Blending, Compression, Coating and Packaging.
- Experience materials inward, issue of Inventory cards for inward materials and affixing of status labels for all the materials.
Validation Analyst
KP Labs
09.2012 - 10.2015
- Drafting and executing IQ/OQ/PQ protocols for various manufacturing equipments and controlled temperature units.
- Performs QA on the floor activities supporting manufacturing process, reviewing documentation in real time and resolving issues that occur during manufacturing.
- Perform Audit of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices.
- Act as QA reviewer for Investigations, Deviations and Change Controls.
- Performed temperature mapping, thermocouple calibration using the Kaye systems.
- Responsible for reviewing and updating the User Requirements Specification (URS) and Functional Requirement Specifications (FRS).
- Performed qualification of manufacturing equipments like blenders and coating machines.
- Performed Calibrations for laboratory equipments like analytical balances, Hardness tester, Disintegration, Friabilator, Moisture analyzers, Tap density testers.
Education
Master of Science - Chemistry
Lamar University
Beaumont, TX12-2017
Bachelors in Pharmacy - Pharmacy
JNTU
Hyderabad, Telangana, India.06-2012
Skills
- Validation
- Temperature mapping
- Technical documentation
- Audit preparation
- IQ/OQ/PQ
- Test method validation
- Commissioning
- Qualification
- SOP's
- BMRAM
- QUMAS
- Equipment calibration
- Valgenesis
- Manufacturing operations
- Root Cause analysis
- Cleaning validation
- Kaye validator
- Data loggers
- Incubators
- Freezers
- Refrigerators
- Coolers
- Autoclaves
- Tablet punching machines
- Blenders
- Tablet Coating machines
- Fluid bed dryers
- Packaging equipment
EQUIPMENT
Timeline
Validation Specialist Consultant
Regeneron Pharmaceuticals Inc
07.2021 - Current
QA Validation
Ascent Pharmaceuticals
03.2018 - 07.2021
Validation Analyst
KP Labs
09.2012 - 10.2015
Master of Science - Chemistry
Lamar University
Bachelors in Pharmacy - Pharmacy
JNTU
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