• A result driven, Lean Six Sigma (LSS) hands-on individual with more than 16 years of IT experience specializing in Computer System Validation, PDLC and Process Control Quality Assurance.• Solid knowledge in Manual and Automated software testing, ISPE GAMP, CMMI, LSS and extensive experience in Computer System Validation, Software development methodologies including both Agile and Waterfall models.• Experience on industries practice in Life science/Pharmaceutical, Health information technology, 21 CFR Part 11 Validation and GxP FDA regulations, Change Control Management, Good Document Practice, CAPA, Risk Management, Test Management and implementation of process controls.• Process Quality Assurance expert in formulating the process for the PDLC using CMMI level 3 and ISPE GAMP process controls. • Have successfully managed more than 33 Compliance/Quality audits from top 10 Pharmaceutical companies. • Experienced in working with Offshore/Onsite developers and testing teams, managing Software QA Projects from concept through maintenance and providing on-time deliverables with highest quality to the aggressive deadline.• Excellent communication, presentation, and interpersonal skills. Good team player with the ability to lead, manage and work independently in a timely sensitive environment. • Working knowledge of a high volume application testing environment for the Pharmaceutical industry with a project team through the validation process.• Involved in every step of the IT SQA/Validation of Operational Qualification (OQ) that was carried out through activities of Computer System Validation.• Involved in CMMI Level 3 (Dev 1.3) assessment and was successful in achieving CMMI Lev 3.• Has successfully implement LSS programs and achieved desired results.• Have built the training department from ground up and successfully maintained the department. • Have mentored & built the industry standard Testing & Validation team
Listed skills include Validation, Pharmaceutical Industry, Sdlc, Quality Assurance, and 31 others.
