Job Description :
10+ Years of experience in performing validation of processes, equipment, utilities that are required to be validated by ISO 13485, FDA''s 21 CFR Part 820 (Quality System Regulation) and 21 CFR Part 11. Good knowledge of mentioned regulation requirements.
      Stong Process Validation, Equipment Qualification, Test Method validation experience in a medical device company is must.
      Experience with qualifying equipment after moving to a new facility. 
      The systems in scope include, but not limited to, GxP software, processes, equipment, utilities, electronic batch records, software used in quality control tests, customer complaints processing, PLM, MES, and ERP systems.
      Identify any regulatory non compliances that need to be addressed and evaluating proposed solutions from a compliance perspective
      Assure that the validations are conducted in a manner that meets regulatory compliance requirements, that is, are performed in compliance with relevant PBI''s procedures.
      Manage validation aspects of the project and inform management in a timely fashion of compliance risks and their potential consequences.
      Lead creation of validation deliverables such as qualification plans, requirements/design specifications, risk analyses, FAT, IQ/OQ/PQ protocols and validation reports.
      Review executed protocols for compliance with good record keeping practices.
      Define a strategy & timeline for completing the validation and ensure timely completion of the project(s
      Perform validation scope assessment for various systems/processes.
      Recommend improvements to new and existing validation templates and procedures, in an effort to adhere to standards, and to simplify the process.
      Training: Train Company personnel involved in Process validation in support of creating ISO & FDA training and awareness. 

Please feel free to reach me at sudhakar at keylent dot com OR call me at 4 0 7 4 8 2 1 4 9 3