Aniruthan S.
CQV Engineer @ LFB | cGMP | GAMP5
- Role
- Cqv Engineer at LFB
- Location
- Framingham, MA, US
- LinkedIn followers
- 500 followers
About Aniruthan S.
I am a CQV Engineer at LFB, a leading global biopharmaceutical company, where I ensure…
Experience
Cqv Engineer
Mar 2022 — Present · Framingham, MA, US
Primary responsible for qualifying Temperature Control Units and Quality Control equipment, including the generation, review, and execution of RTMs, URS, and Validation Protocols. Additionally, involved in CAPA, Change Control, and addressing and resolving discrepancies and deviations in procedural and equipment-based contexts. Performed commissioning, decommissioning, and onboarding qualification of TCUs and QC equipment, utilizing Kaye Validator and Ellab, and generated corresponding reports. Conducted UAT for Remediation Protocol in Rees Scientific Centron Presidio Software. Documented qualification test protocols, calibration/preventative maintenance SOPs, gap analysis, and summary reports. Drafted SOPs for equipment handling, including Validation Policies and Change Control Procedures. Developed Traceability Matrix document for mapping the URS, FRS, IQ, OQ, and PQs. Developed and reviewed validation deliverables, including Master Plans, Protocols, Specifications, Summary Reports, Gap Analysis, Remediation Plans, Risk Assessment, and Training Materials, ensuring compliance with 21 CFR Part 11, GAMP 5, and GMP FDA Regulations. Aided in CAPA management by extracting Complaints data from Smart Solve system. Managed Change Control in SharePoint, creating and implementing Change Request forms. Collaborated with external vendors for qualifying Utilities and Equipment. Conducted Functional Risk Assessments, identified controls, and performed SME reviews for qualification protocols, providing solutions for discrepancies and deviations. Generated Equipment Turnover Package for Installation Qualification and conducted Periodic Reviews for Validation and Manufacturing SOPs. Managed work orders, calibration/maintenance reports, and system details on Blue Mountain Regulatory Asset Manager (BMRAM).
Education
Texas A&M University
Master's degree
2019 — 2021
SRM University
Bachelor of Technology - BTech
2014 — 2018
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