*Work independently in executing the validation activities in qualifying the Controlled Temperature Units (CTUs) such as Incubators, Autoclave, Cold Rooms, Freezers, Refrigerators, and other manufacturing equipment. *Performing temperature mapping and humidity monitoring using Kaye validator & Ellab Portable data-loggers for Manufacturing & laboratory support equipment which require temperature and humidity control.*Authorise, review, and manage the validation final reports for multiple projects that involve qualification of laboratory and manufacturing equipment, processes, utilities, and facilities and routed them in QDM.Provided general validation support in writing and executing process validation protocols including DQ, IQ, OQ, PQ, CQ, RQ protocols.*Coordinated with various departments like Manufacturing, QA, QC, QAD for Validation activities.*Reviewed validation documents ensuring GMP compliance.

*Developed Quality control plans to reduce contamination in catheter manufacturing.*Organised and assigned deliverables to meet CAPA Health Index scores for the entire site. *Ensured Quality Metrics were met as per the Company’s standards by coordinating with multiple sites of Abbott Vascular. *Trace and contained Finished catheters and materials as part of Non-conformance projects. *Developed PFMEAs, Test Method Validation, and process validation documents.*Updated and reviewed DFMEA, PFMEA documents, DQ/IQ/OQ validation protocols.*Supported design verification / validation activities including protocol and report writing.*Supported investigations of nonconformance and CAPAs for operations, supply chain, supporting laboratories and other related functional areas.*Provided new staff training on regulatory requirements, specialising in GMP/QSR.*Monitored, maintained, and controlled the QMS for regulatory purposes under ISO 13485 standards.

*Authored/ reviewed DQ/IQ/ OQ/PQ protocols, user requirements and final summary report for GMP equipment, CTU’s (Controlled Temperature Units) and critical utilities. Qualification includes Cold room, Freezers, Incubators, single use mixers, bioreactors, bench-top equipment’s, steam, WFI, purified water, clean air, nitrogen, oxygen, CO2, steam, autoclaves, insulators, part washers etc.*Performed GAP assessment and took corrective actions to the observed gaps, while reviewing the control historic documents.*Perform regular CIP and COP related to Tanks, Parts washers, and Manual Cleaning equipment.*Maintained and updated requirement traceability matrices to track requirements that correlated with the conducted test cases for CIP skids.*Performed clean and dirty whole-time studies, rinse/swabbing sampling, water batching/vessel mixing studies and performance of CIP on process equipment and transfer lines.

*Executed and maintained a successful cleaning validation program.*Assessed equipment and products and their impact on routine processes and prepared Cleaning Validation Master Plans (VMP).*Identified appropriate cleaning methods/agents and developed acceptance criteria for the residuals and degree of evaluation required to validate the process.*Determined sampling and analytical methods for recovery and detection of residues swab/rinse, HPLC/dry residue.