Hi, I’m Amala K, a results-driven Quality & Validation Engineer with 5+ years delivering compliant, audit-ready validation programs across pharmaceutical, biotech, and medical device sectors. I excel at building cross-functional partnerships, driving continuous improvement, and ensuring product quality and regulatory compliance from development through manufacturing. I bring deep expertise in FDA 21 CFR Part 11, ISO 13485, cGMP, and CSV, with a proven track record of reducing non-conformances and boosting documentation efficiency. I’ve led end-to-end IQ/OQ/PQ for devices and systems, established design controls and traceability, and created real-time quality dashboards for executive leadership.…

Sangeetha Goli

Hi, I’m Amala K, a results-driven Quality & Validation Engineer with 5+ years delivering compliant, audit-ready validation programs across pharmaceutical, biotech, and medical device sectors. I excel at building cross-functional partnerships, driving continuous improvement, and ensuring product quality and regulatory compliance from development through manufacturing. I bring deep expertise in FDA 21 CFR Part 11, ISO 13485, cGMP, and CSV, with a proven track record of reducing non-conformances and boosting documentation efficiency. I’ve led end-to-end IQ/OQ/PQ for devices and systems, established design controls and traceability, and created real-time quality dashboards for executive leadership.…

Available to hire

Hi, I’m Amala K, a results-driven Quality & Validation Engineer with 5+ years delivering compliant, audit-ready validation programs across pharmaceutical, biotech, and medical device sectors. I excel at building cross-functional partnerships, driving continuous improvement, and ensuring product quality and regulatory compliance from development through manufacturing.

I bring deep expertise in FDA 21 CFR Part 11, ISO 13485, cGMP, and CSV, with a proven track record of reducing non-conformances and boosting documentation efficiency. I’ve led end-to-end IQ/OQ/PQ for devices and systems, established design controls and traceability, and created real-time quality dashboards for executive leadership.

See more

Language

English
Fluent

Work Experience

Quality Engineer at Regeneron
March 1, 2024 - Present
Managed process validation for infusion pumps and automated drug delivery systems under FDA, ISO 13485, and cGMP standards. Designed IQ/OQ/PQ validation protocols for Document Management Systems, incorporating critical mechanical design tolerances into test plans. Closed a 15% reduction in calibration non-conformances by leading a gap analysis against AS9100 and executing targeted corrective actions. Integrated CAD with PLM platforms (Windchill, Teamcenter) to streamline design documentation and change management workflows. Championed Industry 4.0 transition in injection moulding with sensor-based process monitoring and automated data logging. Designed a CAPA metrics dashboard providing executive-level visibility into quality trends and early-warning indicators. Established and enforced Design Controls for full product lifecycle traceability, ensuring audit-readiness for FDA inspections. Validated CNC process parameters to optimize efficiency and minimize production defects.
Quality Engineer at Viatris
March 1, 2023 - February 29, 2024
Delivered a 20% improvement in validation documentation efficiency while maintaining full FDA and ISO 13485 compliance. Executed IQ/OQ/PQ protocols for diagnostic and laboratory equipment, meeting functional and regulatory specifications for product approval. Led DFMEA and PFMEA with cross-functional teams, mitigating design and process risks through the product development cycle. Managed design transfer from development to manufacturing, ensuring seamless handoffs with zero quality escapes. Investigated quality deviations, performed root-cause analysis, and implemented CAPAs that improved product safety and compliance. Prepared all documentation for internal and external regulatory audits — zero findings across inspections. Conducted risk assessments on critical components, addressing failure modes early to reinforce reliability and compliance.
Validation Engineer at Sun Pharma
May 1, 2021 - September 30, 2022
Executed IQ/OQ protocols for HVAC systems supporting ECGs, defibrillators, patient monitors, and anesthesia workstations. Prepared qualification documentation for infusion pumps, oxygen concentrators, and imaging devices. Conducted P&ID reviews, GA drawing walkdowns, and filter integrity tests to maintain GMP-compliant cleanroom environments. Managed GMP change controls for systems across surgical diathermy and diagnostics equipment manufacturing. Identified and escalated validation risks, recommending mitigation strategies to protect timelines and regulatory compliance. Delivered qualification protocols for consumables including ECG electrodes and syringe pumps.

Education

Master of Science in Business Analytics at University of New Haven
January 11, 2030 - May 8, 2026
BTech in Electronics & Communication Engineering at Geethanjali College of Engineering & Technology, India
January 11, 2030 - May 8, 2026

Qualifications

Add your qualifications or awards here.

Industry Experience

Life Sciences, Healthcare, Manufacturing