Aniruthan P Saravanavel Email & Phone Number

Results-driven CQV Validation Engineer with over 5 years of expertise in Computerized Systems, Equipment, Cleaning, and Process Validations. Proven track record in ensuring Pharmaceutical Industries' compliance with GxP regulations through the application of GAMP 5 and risk-based validation methodologies. Proficient in Validation Lifecycle, V-Model, SDLC, and QA Methodologies, with a focus on FDA-regulated environments and adherence to cGxP standards.Key Skills:- Comprehensive experience in preparing and reviewing URS, FRS, IQ, OQ, PQ, and VMP.- Active involvement in Deviation, Change Control, Document Control, Audit, Risk, Data Migration, and Training Management.- Utilization of QRM tools for Deviation Management, emphasizing severity, occurrence, and detectability.- Expertise in Risk Assessment, Gap Analysis, and Internal Audits for various software applications and systems.- Efficient in 21 CFR Part 11 Gap Analysis, HLRA, and Remediation Plans development.- Validation of laboratory equipment, including Biosafety Cabinets, Laminar Flow Hood, Fume Hood, HPLC, AHU HVAC System, and Spectrophotometer.- Proficient in process monitoring and analysis of process capability and performance (Cpk, Ppk).- Expert in NCR process, CAPA assessment, and evaluation of applied Corrective Action Results (CAR).- Skilled in conducting Root Cause Analysis (RCA), and Failure Mode and Effects Analysis (FMEA).Achievements:- Successful collaboration with clients to ensure compliance with GxP regulations in computerized systems.- Implementation of risk-based validation methodologies, resulting in streamlined processes and improved efficiency.- Proven track record in managing various aspects of validation projects, including documentation, deviation management, and audits.Efficient and adept at navigating complex regulatory landscapes, ensuring high standards of quality and compliance in the pharmaceutical industry.