Headline

Biopharma Manufacturing & Quality Systems | GMP, Validation, Documentation, Deviation handling | Single-Use Technologies (SUTs) | IV bags | blood bags | Medical devices | ISO 13485 |

About

Performed batch documentation, BMR/BPR review, and real-time GDP compliance, minimizing documentation errors and improving traceability 📋 Managed end-to-end manufacturing of single-use bioprocess systems (2D/3D bags, tube assemblies, liners) in ISO-classified cleanroom environments, ensuring adherence to GMP guidelines and SOPs 🏭 Actively involved in deviation identification, investigation support, and CAPA implementation, contributing to reduction in recurring non conference 🔍 Ensured line clearance, in-process checks, and product quality verification in coordination with QA to maintain compliance standards ✅ Supported internal audits and client inspections by maintaining audit-ready documentation and shop-floor compliance 📂 Collaborated cross-functionally with QA/QC and Engineering for change control, validation activities, and process improvements ⚙️ Contributed to process validation (IQ/OQ/PQ support) and ensured consistent execution of validated procedures 🧪

Location

Silvassa

Work experience

Technical application Engineer (Senior Executive) at Ami Polymer, Apr 2026 - Present · 3 mos, Silvassa, Daman and Diu, India

Technical application Engineer (Executive) at Ami Polymer, May 2025 - May 2026 · 1 yr 1 mo

Officer at Ami Polymer, Apr 2024 - May 2025 · 1 yr 2 mos, Silvassa

Education

Master's in Biotechnology, Biotechnology, Uka Tarsadia University

Bachelor's degree, Biotechnology, Uka Tarsadia University