Summary
Overview
Work History
Education
Skills
Certification
Timeline
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VISHNU MANJITH SURA

Quality Assurance Officer
Maidenhead,United Kingdom

Summary

As a dedicated and diligent Quality Assurance Officer with over 3+ years of experience, I am committed to meticulously evaluating product quality and manufacturing processes to ensure outstanding outcomes and customer satisfaction. My passion for this field has bolstered my proficiency and exceptional organizational skills. I possess a working knowledge of both internal and external audit processes, enabling swift and effective action. I am a strong motivator, well-spoken, and dynamic, with a commitment to excellence in personal, product, and system development.

Overview

5
5
years of professional experience
5
5
years of post-secondary education
1
1
Certification

Work History

Quality Assurance Officer

NOUMED LIFE SCIENCES
10.2022 - 1 2024
  • Create, review, revise, and maintain controlled documents such as standard operating procedures (SOPs), protocols, batch records, and other quality-related documents
  • Ensure that documents are organized, cataloged, and stored in easily accessible and secure manner, often using electronic document management systems (EDMS)
  • Maintain historical records of document changes and revisions
  • Reviewing and approving of Batch Manufacturing Records
  • Assist in preparation for internal and external audits by ensuring that all relevant documents and records are up to date and readily available
  • Reviewing and approving changes to manufacturing processes, procedures, and equipment's
  • Conducting regular internal audits to assess organization's compliance with QMS, identifying areas for improvement, and taking corrective actions as needed
  • Reviewing and approval of Out of specification (OOS) and Out of Trend Investigations (OOT)
  • Identified and resolved manufacturing-related deviations and CAPAs, closing them within targeted timelines, resulting in improved operational efficiency and meeting quality standards
  • Collaborating with other departments, such as Regulatory Affairs, Quality Control and IPQA
  • Maintaining up-to-date knowledge of GMP regulations and industry trends to ensure continuous improvement of quality system
  • Conducted evaluations to identify weak areas and identify problematic issues while promoting corrective methods.

Quality Assurance Associate

BIORASI
07.2021 - 08.2022
  • Implemented robust training tracking system, utilizing learning management system (LMS) to monitor and document employee progress and completion of required training modules, resulting in 25% increase in training completion rates
  • Arranging CEO and respective department heads meetup to new hires
  • Creating New Employee Orientation (NEO), Brief & De-brief Templates for international hires
  • Assist in review of quality systems, processes, and procedures for compliance with applicable Regulatory regulations and ICH guidelines and propose and assist in implementation of targeted quality improvements
  • Review all Standard Operating Procedures, Forms and Templates for compliance, format, and structure with focus on QA and GN SOPs
  • Assist in evaluation of performance and effectiveness of training programs, including recommendations for improvement
  • Assist with development, initiation, and facilitation of Quality Assurance training programs
  • Assist in Document Control: troubleshoot issues, assist, and advise staff
  • To Assist in Vendor Audits and pen-down key points
  • Assign training and development identifier to newly developed materials, update training and development matrix and curriculum catalogue.

Trainee Quality Assurance

SURA PHARMA LABS - HYDERABAD
06.2017 - 08.2018
  • Validated and verified correctness of Batch Manufacturing Record documents, playing critical role in maintaining product consistency and meeting production timelines
  • Orchestrated GEMBA walk initiative in packaging and manufacturing area
  • Handling of customer complaints
  • To facilitate and participate in investigations for deviation and failures
  • Providing Data integrity and GMP awareness training to manufacturing and packaging personnel
  • To facilitate and participate in internal audits, customer audits and regulatory inspections
  • Strictly following GMP & GLP for ensuring safety and integrity of drugs.

Education

Master of Business Administration - Project Management

BPP University
London, ENG
08.2020 - 05.2021

Master of Science - Pharmaceutical Sciences

Kingston University
Kingston Upon Thames
09.2018 - 05.2019

Bachelor of Science - Pharmacy

Kakatiya University
Warangal
08.2013 - 05.2017

Skills

Active Listening

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Certification

Good Clinical Practice Certification - Completed August 2021

Timeline

Quality Assurance Officer

NOUMED LIFE SCIENCES
10.2022 - 1 2024

Quality Assurance Associate

BIORASI
07.2021 - 08.2022

Master of Business Administration - Project Management

BPP University
08.2020 - 05.2021

Master of Science - Pharmaceutical Sciences

Kingston University
09.2018 - 05.2019

Trainee Quality Assurance

SURA PHARMA LABS - HYDERABAD
06.2017 - 08.2018

Bachelor of Science - Pharmacy

Kakatiya University
08.2013 - 05.2017

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VISHNU MANJITH SURAQuality Assurance Officer