Experience

Nulife

• India
• Medical Equipment Manufacturing
• 1 - 100 Employee

• QA/RA Head

  • Oct 2021 - Present

  • Provide product regulatory affairs and quality strategies ( Confidential, EU & Health Canada) and mentor matrix teams on the changing requirements, Regulatory Assessments (RA) and Regulatory Assessment Determination (RAD), quality design controls; serves as U.S Confidential and other regulatory agencies Point of Contact • Develop, train, maintain, deploy & responsible for all elements from the Quality Management System ensuring compliance. • Regulatory submissions - develop technical files, dossiers & submit for market clearance / approvals. • Support commercial for review & approve product marketing claims, promotional publications, digital materials, product compliance letters • Vendors & suppliers management, technical and quality agreements, evaluation of suppliers and subcontractors, build & maintain relationships. • Develop and support R&D, manufacturing & post-marketing quality trending, statistical metrics for management reviews and quarterly updates. • Plan & execute 3rd party audits for compliance as a Certified Lead Auditor; interfacing with regulatory agencies during inspections and findings. • Post-market surveillance streamline complaints, adverse events / MDR reporting, investigation to assure customers satisfaction & prevent reoccurrence. • Develop product quality & regulatory statistical metrics and provide product status reporting to executive management on product quality and regulatory risks with proposed solution. Show less



Johnson & Johnson

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Quality Team Leader

  • Jul 2011 - Dec 2021

   To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements.  Conduct gap analysis for SOPs and regulatory requirements applicable to site and develop action plan to close the gap and mitigate risk.  Responsible for establishing, managing, and implementing Records Management policy, Records Retention and retrieval procedures are in place.  To monitor internal and external audit schedules and follow up on action plan,  To monitor & handle market complaints.  Conducted Management review at site.  Conduct Calibration of instrument & Calibration Matrix Maintain.  To ensure that Annual Product Reviews are performed and evaluated.  Responsible for assessing Quality matrix, trends and driving Continuous improvement for processes and product quality performance. Site sterilization Lead. Show less



Reckitts Benkiser (I)Ltd.(Paras)

• Baddi

• Executive Quality

  • Nov 2008 - Jul 2011

  Responsible for day to day analysis of finished goods and in process sample, generation and execution of related reports. Preparation of respective standard operating procedures (SOP), specifications, method of analysis and STPS for quality control department. To ensure effectiveness of (GLP) Good Laboratory Practices and (GDP) Good documentation practices in daily analysis. Review of Worksheet and Certificate of Analysis for correctness and completeness as per Specification. Review to avaialbity of all laboratory chemicals, Reagents, Glassware, Standards (Reference and working) and Impurities, Chromatographic columns in the laboratories. Responsible for Analyst validation for all new and routine analyst and compilation of records. Ensure usage of current lots, batches of reference standards, working standards and impurities. Ensure calibration and maintenance of all instruments and equipments available in quality control department as per master schedule. Preparation and submission of regulatory required documents. Handling deviations, incidents and OOS results. Show less