Description
* Results-driven, innovative leader with expertise in QA Project/Program Management, thought leadership and mentoring skills with over 15 years of experience in Pharmaceutical, Medical Device Manufacturing/Biomedical, HealthCare, and Financial Industries. * Design and develop the QA Test from the beginning of Business Simulation Test from the Scenarios of the User stories/Requirements to Production readiness Test. * Managed System in compliance with 21 CFR 820 and ISO 13485:2016, communication with regulatory bodies, conducting audits and supporting compliant execution of quality-related processes. * Implemented and transferred of the QMS into the organization and ensuring that it is lived in everyday life. * Proficient in Resource Planning, Budgeting, Risk Management, and Successful Stakeholder Management. * Highly experienced in diverse ERP Systems (SAP, ORACLE, PEOPLESOFT, and SIEBEL etc.), Supply Chain Management, LIMS (Labware, Empower), Pharmacovigilance, Quality, and Compliance. * Led and managed Global CSV (Computer System Validation) teams ensuring compliance with GxP (cGMP, GLP, GCP and GDP) protocols, GAMP as set forth by USFDA, and international regulatory bodies (EU Annex 7, 11, EMA, MHRA, PMDA, QSR, PIC/S, ICH Q10, Eudralex Vol 4 etc.). * SME in the use of structured methodologies for certified testing including Automation Testing using various tools (QTP / UFT, SAP Solution Manager, Rational Suite etc.), Quality Assurance of Mainframe, and Distributed Environment including Cloud Based applications. * Led GxP Auditors, managed testing and validation as per FDA Regulations CFR 21 Part 11, 203,210, 211, 218, 820, 821 and 822 (a) & (b). * Effectively managed Change Controls System Requirements Analyses, Design, cGMP/ GLP Qualification Activities, Continuous Process Improvement Activities. * Conducted FMEA to assess risk and identify risk mitigation actions * Completed Annual Product Quality Reports (APQR) * Provided corporate training in CSV and End to End Testing Globally. * Worked with Global Cross functional teams to determine Product Line Readiness * Possess excellent organizational, managerial and interpersonal skills. * Experienced in project management in multi-project and multi-cultural setup.
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