Headline

Quality Assurance Professional| Global QMS, ISO 9001, 14001, 45001 and FDA 21 CFR part 11, GAMP 5, cGMP USA &European| CAPA, Process Auditing & Root Cause Analysis | 5+ overall Years Pharma.

About

Quality Assurance Engineer with 3+ years of experience in precision pharmaceutical packaging and process equipment manufacturing at ACG World(MNC). Experienced in incoming material inspection, in-process quality control, final inspection, supplier quality support, CAPA, and quality documentation for high-speed pharmaceutical machinery manufacturing. Contributed to reduction in rejection, improvement in inspection efficiency, process compliance, and manufacturing quality performance through Root Cause Analysis (RCA), process monitoring, and quality improvement initiatives. Skilled in dimensional inspection, engineering drawing interpretation, ERP systems, ISO 9001 quality systems, cGMP practices, and US FDA 21 CFR Part 11 data integrity requirements.

Location

Pune/Pimpri-Chinchwad Area

AI stack

antigravity

cursor

Work experience

Quality Assurance Engineer at ACG World, Jan 2021 - Present · 5 yrs 7 mos, Pune/Pimpri-Chinchwad Area, As a Quality Assurance Engineer at ACG World since January 2023, I am responsible for performing detailed incoming and outgoing material inspections of mechanical, electrical, and instrumentation components, including panels, tubing, fittings, sensors, transmitters, and integrated assemblies. My core duties include verifying material compliance against Purchase Orders, BOM, P&ID, GA drawings, wiring diagrams, and technical specifications using precision measuring instruments such as vernier calipers, micrometers, height gauges, dial indicators, plug gauges, and bore gauges. I conduct functional testing and calibration of sensors and transmitters to ensure calibration readiness and performance, maintain comprehensive quality documentation including inspection reports, test certificates, calibration certificates, and full traceability records in alignment with ISO 9001-aligned Integrated Management System processes (supporting ISO 9001, 14001, and 45001 principles), identify and manage non-conformances (NCRs) through root cause analysis and coordination of corrective and preventive actions (CAPA) with vendors and internal teams, and support customer inspections/acceptance by preparing documentation and demonstrating system functionality. Additionally, I utilize advanced MS Office features along with Copilot AI tools to automate quality metrics analysis, generate trend reports and dashboards, streamline inspection documentation, and enhance data-driven decision-making, contributing to significant improvements in process efficiency, reduced rejection rates, lower rework costs, enhanced audit readiness, and overall operational excellence.

Education

Bachelor of Technology - BTech, Mechanical Engineering, shivaji university