Amuluru Ramesh

About Amuluru Ramesh

Experienced Technical trainer with experience in pharmaceutical and medical device industry with Hands on Experience on In-process Quality Assurance, Quality Management system (QMS), Incident & Investigations, Root cause Analysis, CAPA and Documentation activities, post marketing surveillance(Market Complaints).• Responsible for in taking the complaint, validating the complaint, Escalating the Adverse Events, investigating and reviewing the complaint for the closure.• Executed Cleaning validation and process validation protocols, Collected and submitted samples for the QC Department.• Performed incidents, investigations, Root cause analysis, Corrective actions and Preventive actions.• Involved in the activities like GAP Assessments, Product Quality Assessments (PQA), 483 CAPAs, Warning Letter Commitments, Critical Quality Events (CQE), Field Alert Reporting (FAR), Recalls.• Acquired knowledge on Computer system validation, Regulatory Affairs, Quality Engineering Roles and responsibilities.• Strong knowledge on Design Controls, Design verification and validation activities, DHF, DMR,DHR,NCMR, NCR, Process Validation (IQ, OQ,PQ), validation Summary Report, EU MDR,ISO 13485, ISO 14971, ISO 14644, ISO 10993,ICH Guidelines.

Experience

1. Technical Trainer

   Intellectt Inc

   May 2022 — Present · Vijayawada, IN

Education

• JNTU Anantapur

  Masters in pharmacy

  2012 — 2014