| | | 20,000+ Fresh Resumes Monthly | |
|
|
| |
Click here or scroll down to respond to this candidateCandidate's Name
PHONE NUMBER AVAILABLEEMAIL AVAILABLESUMMARYDedicated and detail-oriented Quality professional in the medical and pharmaceutical industries. Proven track record of ensuring compliance with regulatory standards (FDA, GMP,) and implementing quality management systems. Skilled in leading cross-functional teams, conducting audits, and driving process improvements to enhance product quality and regulatory compliance. Strong expertise in risk management, validation, and documentation control. Seeking to leverage background and skills in a challenging Quality role within the medical or pharmaceutical sector.TECHNICAL SKILLSQuality Management Systems (QMS) ImplementationRegulatory Compliance (FDA, GMP,)Risk Management (ISO 14971)Validation (Process, Equipment, Software)Audit ManagementDocument ControlCAPA (Corrective and Preventive Actions)Root Cause AnalysisAnalytical Method ValidationGMP/GDP (Good Manufacturing Practices/Good Distribution Practices)SOP Development and ReviewElectronic Quality Management Systems (eQMS)Change Control ManagementA3s/5Whys/DMIAC GREEN BELT & BLACK BELT Certified.Professional ExperienceQuality Assurance/Engineer, NorthStar Medical Radioisotopes, Beloit, WI Mar 2022- Jan 2024-Led a team of 8 QA specialists in the implementation of a robust Quality Management System (QMS), resulting in a 20% improvement in operational efficiency and compliance.-Ensure that there is coordination of Internal trainings to the entire related department.-Consistently perform at a high level, manages time and workload effectively to meet responsibilities.-Drafting of batch records and maintaining of electronic laboratory notebooks (ELNs).-Establishing relation with equipment and excipient manufacturers / vendors and maintaining all the required documentation.-BMR and BPR preparations and Issuance and process relative activity in the ERP system.-Provide technical support and day-to-day management of outsourced drug product development activities with CMO partners for clinical supplies.-Drafting, reviewing and approval of batch manufacturing records, protocols, SOPs and developmental reports.-Responsible for implementation of new procedures and controls.-Tracking and reporting progress of multiple projects.-Assisted in the investigation and resolution of non-conformance incidents, contributing to a 25% reduction in product recalls over a 3-year period.-Responsible for initiation and investigation of deviations, CAPAs, and change controls.-Regular monitoring of calibration and preventive maintenance status of all the production equipments.-Participated in internal and external audits, which are held biannually.-Collaborated with R&D and manufacturing teams to identify and implement quality improvements during the product development lifecycle, reducing time to market for new products.-Followed and implemented FDA Quality System Regulation, GLP, GMP Guidelines, Medical Device Directive, ISO, and other international regulatory requirements.-Collaborated with cross-functional teams to facilitate Risk Management activities such as Design FMEA, Process FMEA, and Risk Analysis.-Measuring supplier quality performance and driving appropriate improvements to meet established targets (Delivery, SCARs, NCRs, etc.).-Worked with Change Orders, document submission and approvals under Product Life Cycle Management (PLM) - Oracle Agile.-Familiar with Quality System Requirements (21 CFR 820, ISO 13485, and FDA regulatory-compliance). Authoring and implementing Engineering Change (ECO) & SOPs utilizing Arena.-PLM tool, managing Design Requirements traceability & defects mitigation utilizing Test Track-tool.Manufacturing Quality Engineer, Zimmer Biomet, Warsaw, IN Aug 2020- Feb 2022-Investigated the scope, cause, and correction plan of 200+ non-conformance related with end of line and clean rooms.-Competence with drafting standards and GD&T-Developed and executed IQ, OQ & PQs for manufacturing processes and supporting manufacturing equipment and instrumentation.-Assisted in 25+ off-track orders to continue the manufacturing process with router maintenance as per JDE.-Facilitate the cross-functional team to identify, evaluate, investigate and resolve issues that are extended to suppliers.-Evaluated the most appropriate method to correct and prevent issue related actions by communicating with appropriate personnel such operators, supervisors, quality and manufacturing engineers.-Analyzed engineering specification, inspection method and sampling plans, testing and post implementation support.-Assisted in creating, maintaining and improving controlled technical documents, routers, BOM, and recorded data.-Studied, self-trained through ilearn and executed the quality, safety and efficient practice.-Learning and understanding of concepts and principles for manufacturing and product processing in area majorly focusing on quality, development and sourcing.-Led the feasibility study to estimate product cost and analyze capital equipment, capacity and capability requirement.-Identified the lean manufacturing waste. Hence supported the cost saving project by improving efficient manufacturing process methods to increase performance and quality requirement.-Wrote SOPs, work instructions, and quality alerts to align work methods and inspections with the overall company quality policy.-Reviewed and created Non-Conformance Material Report (NCMRs). Perform incoming inspection of parts and ensures the continuous flow of quality materials.Quality Assurance/Engineer, Magnus Pharma, NPL Jun 2019- July 2020-Implemented and maintained the effectiveness of the quality system interpreting the engineering schematics.-Reviewed documents related to DHF, DHR, DMR, Design and Development, Validation, and Verification for Regulatory compliance.-Support validation efforts and requirements for timely move/relocation of equipment and technology transfer, including the generation of IQs, OQs & PQs protocols, execution, and reports.-Measured, Evaluated and Verified precision and accuracy of the instrument using Gage R&R methodologies.-Verified the stability, safety, efficacy, and quality of the instrument with load under normal operating condition.-Identified the non-conformance, initiation of root cause investigation followed by troubleshoot/ problem solving.-Record and document all the events, actions and ideas to prioritize and implement the improvement projects.-Used 5 whys, A3s and DMAIC methodologies to resolve issues and improve efficiency and effectiveness of processes-Participated in continuous improvements/quality initiatives with quality and manufacturing engineers to implement, maintain and enhance production process to achieve quality and profitability matrices.-Ensure technical documentation is presented in a clear; complete; accurate; and concise manner.-Update and revise the Risk Management file for legacy products.-Aware of ISO standard for quality, environmental, health, safety and energy global policies - Organized offsite team building exercises to collaborate and maintain strong relationships with colleagues.-Handling of change control, deviation and to tale corrective and preventive actions on identified deficiencies, nonconformities and risk areas.EducationRAJIV GANDHI UNIVERSITY OF HEALTH & SCIENCES Bangalore, INDIAMaster of Pharmacy: Aug 2017-May -2019CertificatesCertificate Of Completion Six Sigma Yellow Belt, Green Belt & Black Belt.Technical Skills and ToolsQA, PFMEA, DFMEA, IS0, FDA, CAPA, Gant Charts, SOPs, WI, IQ/OQ/PQ, TMV, Technical Report,MSA, Lean Six Sigma, Project Management, DOE, GxP, GMP. |
