KEY COMPETIENCES
I excel in monitoring processes, inspecting products, and analyzing quality data. I’ve contributed to achieving high standards of quality in manufacturing and have been recognized for my dedication to excellence.
Technical Writing & Document Control
Authored, reviewed, revised and approved SOP, Protocols, Reports, Log-sheets, log-books, Trend Reports. Led Change Controls, Deviations, Complaints, CAPA, RCA to support the timely closure of NCRs/CAPAs.
Quality Assurance/Quality Control
Performed method development/validation and analytical testing of manufacturing batches, clinical trial material, API and vaccines, ensuring compliance to SOPs, cGMP, GLP and Pharmacopeias (USP/EP). Performed risk assessment and risk management as per ICH Q9 utilizing FMEA tools.
Equipment Handling/Qualification
Leveraged techniques proficiency in HPLC, Osmolality, TOC, Conductivity, UV-Vis (A280), ELISA, SDS-PAGE, Western Blot, Cloning, Transformation, PCR, BCA, and Bradford. Participated in analytical equipment qualification (IQ/OQ/PQ) and calibration operations, and supported in preparing documents for maintenance, purchase and installations
Regulatory Affairs/Auditing
Participated in internal & external audits, responding to quality-related queries, and provided documents indicating adherence to ISO, ICH, FDA and Health Canada regulations
Lean-6Sigma/Continuous Improvement
Assisted with mapping of various processes for continuous improvements including 5S implementation for Equipment, Logbooks and reagents inventory
Computer Expertise
Leveraged software proficiency including Google Suite, Excel, Minitab, R-studio, managed documents in eDMS including LIMS, Track Wise Digital, Compliance Wire, KneatX, and Veeva.
Achievements
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Zero Defect Award
Recognized for achieving zero defects in product inspection for six consecutive months.
Continuous Learning
Regularly attend workshops to stay updated with the latest in quality control techniques.
Process Improvement
Implemented a process improvement that increased inspection efficiency by 20%.