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
Strong attention to detail and analytical skills
Excellent communication and interpersonal skills
Knowledge of quality management systems and methodologies
Proficiency in MS Excel
Problem-solving and root cause analysis abilities
Ability to work independently and as part of a team
Proficiency in data analysis and reporting
Time management and organizational skills
Active Listening
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