Quality Assurance Professional - Mission Foods
(2025-03)
A Detailed-oriented Quality Assurance professional with experience in GMP compliance, traceability, Internal Audits, laboratory testing and quality systems within a manufacturing environment. I am skilled in quality inspections, microbiological sampling, Deviations, CAPA activities, SAP (daily reports, Hold/Reject Products, SOPs etc...,) and cross-functional collaboration to maintain product safety and regulatory compliance.
- Certified in Food Safety Level 2 & 3 and HACCP Level 3
Technical Officer- International Marketing [Europe] - Hetero Labs Limited
(2023-08 - 2024-09)
- Collaborated closely with Quality Assurance and R&D teams to troubleshoot technical issues, optimize workflows, and ensure enhanced API quality and consistent product performance.
- Ensured GMP and data integrity alignment across customer-facing technical documentation (COAs, standards, reference samples), strengthening audit readiness and client confidence.
- Reviewed and coordinated Quality Agreements and CDAs, confirming compliance commitments and change-notification pathways with EU customers.
- Triaged and closed client technical queries by consolidating QA/QC, R&D, and production inputs; provided defensible API data packages and maintained traceable records.
- Managed end-to-end sample and standards dispatch with chain-of-custody tracking, supporting external analytical verification and method assessments.
- Used sales/quality trend analysis to inform risk-based prioritization of technical support, contributing to on-time delivery and reduced repeat queries.
Chemist- Quality Assurance - Hetero Drugs Limited
(2021-09 - 2023-08)
- Led authoring, execution, and reporting of process and cleaning validation protocols in line with ICH Q7 and FDA 21 CFR 210/211; improved yield and process consistency while demonstrating state of control.
- Executed and documented cleaning validation lifecycle activities (MACO calculations, swab/rinse sampling plans, worst-case selection), achieving compliant equipment release and reduced carryover risk.
- Performed QA review of QC analytical data and microbiology/water system trends (purified, potable, DM), ensuring timely assessments, OOS/OOT escalation, and accurate record updates.
- Investigated deviations, incidents, and OOS results using structured RCA; implemented CAPAs and verified effectiveness; supported revalidation where impact warranted.
- Administered change controls covering process, equipment, methods, and systems; completed impact assessments, documentation updates, and training coordination to maintain compliance.
- Prepared/reviewed APQRs to evaluate process performance and product quality, driving continuous improvement actions and stability/validation recommendations.
- Managed controlled documents: issuance, effective-date retrieval, logbook oversight, and archival; improved document right-first time and retrieval efficiency.
- Participated in regulatory (ANVISA), customer, and internal audits; collated objective evidence, addressed observations within agreed timelines, and sustained audit readiness.
- Supported CQA/customer teams with dossier materials (DMFs, STPs, SOPs), coordinated responses, and maintained submission trackers to enhance transparency and turnaround times.
- Trained cross-functional teams (Warehouse, Production, QC, QA, Safety) on validation and GMP documentation standards to elevate first-pass compliance.
