Shyamkumar Patel
PharmD, MS, RPh
- Role
- Manufacturing Quality Assurance Specialist-i at Kashiv BioSciences LLC
- Location
- Edison, NJ, US
- LinkedIn followers
- 500 followers
About Shyamkumar Patel
PharmD and MS in Pharmaceutical Sciences graduate with over 1 year of experience in…
Experience
Manufacturing Quality Assurance Specialist-i
Dec 2024 — Present · Piscataway, NJ, US
Perform line clearance and in-process line inspections during manufacturing to ensure cleanliness, proper labeling, and readiness per SOPs and cGMP standards.Review and approve Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) for completeness, accuracy, and compliance before final product release.Monitor and evaluate audit trails of GMP electronic systems (e.g, MasterControl, BMRAM,LIMS, ERP) to ensure data integrity in compliance with ALCOA+ principles.Conduct regular GMP walkthrough audits across manufacturing, QC lab, and warehouse areas to verify compliance with standard procedures and identify potential gaps.Oversee raw material and critical material release, ensuring verification of COAs, correct labeling, and expiration/retest dates before use in production.Review quality event documentation, including deviations, change controls, CAPAs, and out-of-specification reports, ensuring thorough investigation and resolution.Support regulatory inspections and internal audits, handling documentation requests and responding to auditor queries efficiently.Execute cleaning and sanitization activities in classified areas (ISO 7 cleanroom, ISO 5 laminar flow hood) and document per protocol.Provide backup and support to other QA functions, and contribute to quality improvement initiatives led by Quality Management.Assist in staff training and implementation of updated procedures to align with evolving regulatory and operational requirements.
Education
PARUL INSTITUTE OF PHARMACY & RESEARCH 214
Pharm.D
2016 — 2022
Harrisburg University of Science and Technology
Master of Science - MS, Pharmaceutical Sciences
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