Raj Chakra

About Raj Chakra

Lean Six Sigma and Business Analytics Certified with ~16 Yrs of experience in Quality and…

Experience

1. Team Lead - Quality

   Tech Mahindra

   Sep 2014 — Present · Hyderabad, IN

   Leading a team of Sr. QAs working on Legal & Non-Legal Case Processing (ICSR) and Data Migration, as well as in Patient Support Program & Artwork Creation and Proofreading projects• Motivating the team, providing regular feedback and offering step-up opportunities to develop advanced skills and performance improvement• Driving Quality Management System and Operational Excellence projects to make continuous process improvement yielding agreed targets on quality and throughput• Identification of potential process improvement and automation opportunities and driving projects for improvement• Collection, review and analysis of data to provide meaningful insights to stakeholders for business decision making• Identification of root causes for any non-conformances and proposing CAPA using different problem solving tools such as Brainstorming, Fishbone, 5Y, 8D, etc. to close the gaps• Training staffs on Operational Excellence Tools & promote culture of Kaizen• Conducting Risk Analysis and FMEA for any new process or SOPs or any modification in existing process or SOPs (Internal and External)• Periodic review and maintenance of SOPs and guideline documents for audit readiness• Conducting internal audits to ensure adherence to SOPs or guideline documents, and deviations are justified and documented• Participating in all internal and external audits• Recruiting and Mentoring new hires - Conducting Quality Induction/Orientation sessions for new hires

Skills

• Pharmacovigilance
• Documenting and Analyzing Pharmaceutical and Clinical Research Data
• Quality Control
• Abstract Writing, Medical Writing
• Detecting and Assessing Drug Safety (Sae/Ae) From Scientific Medical Documents
• Standards Compliance
• Scientific Writing
• Microbiology
• Team Management
• Iso 9000
• Case Processing
• Clinical Pharmacology
• Sop
• Management
• Knowledge on Multiple Therapeutic Areas
• Knowledge on Clinical Trial Phases (Preclinical/Clinical)
• Gcp
• Pharmacoepidemiology
• Microsoft Office
• Clinical Trials
• Internal Audit
• Ich-Gcp
• Project Management
• Root Cause Analysis
• Six Sigma
• Process Improvement
• Pharmacogenomics
• Quality Management
• Psychiatry
• Clinical Research
• 7 Qc Tools
• Provide Leadership on Preparation and Review of Scientific Medical Documents
• Pharmaceutical Industry
• Narrative
• Quality Assurance
• Provide Training/Mentorship to Colleagues
• Pharmacokinetics
• Argus Safety