Pooja Sharma
London,United Kingdom
Summary
Accomplished professional with expertise in regulatory standards and quality consciousness, demonstrating proficiency in software testing and auditing techniques. Skilled in utilising quality control tools and participating in USFDA, MHRA, and EU audits to ensure compliance and excellence. Adept at business analysis techniques and data analysis tools, with advanced capabilities in Microsoft Excel, PowerPoint, and MS Word. Committed to leveraging analytical skills to drive organizational success while pursuing opportunities for continuous improvement within the quality assurance domain.
Overview
5
5
years of professional experience
Work history
Quality Assurance Executive
Acme Formulation Pvt. Ltd.
Nalagarh, India
02.2022 - 02.2025
- Led software qualification initiatives ensuring compliance with regulatory standards and industry best practices.
- Developed and maintained comprehensive test plans and documentation for software validation processes.
- Responsible for Initiating, review and approval of Change control, Deviation, Incident CAPA.
- Responsible to Prepare all documents related to Self Inspection.
- Responsible for conducting Self-inspection as Per Frequency.
- Responsible for Preparation of Quality review meeting Data.
- Collaborated with cross-functional teams to identify and resolve software issues during qualification phases.
- Effectively Qualified and implemented Elog, LMS, EQMS, and EDCS software at site.
- Conducted rigorous testing and analysis of software applications to ensure reliability and performance.
- Trained and mentored junior staff on software qualification methodologies and compliance requirements.
- Evaluated and reported on software performance metrics to support continuous improvement efforts.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Supported team by demonstrating respect and willingness to help.
- Worked flexible hours, covering nights, weekends and bank holidays.
- Consistently arrived at work on time and ready to start immediately.
- Increased customer satisfaction by resolving issues.
- Used Microsoft Word and other software tools to create documents and clear communications.
- Led data preparation initiatives to ensure accuracy and compliance with project requirements.
- Streamlined data workflows by identifying and eliminating inefficiencies in existing processes.
- Developed and implemented data validation processes to enhance data integrity and reliability.
- Utilised advanced data management tools to prepare and organise data for analysis and presentation.
- Conducted thorough reviews of data sets to identify discrepancies and resolve issues promptly.
- Assisted in the creation of documentation and training materials to support data preparation efforts.
Quality assurance officer
Indoco Remedies Ltd.
Baddi, India
09.2019 - 02.2022
- Collaborated with team members to identify potential areas for quality improvement.
- Participated in training sessions to enhance knowledge of quality assurance practices.
- Supported the management of quality records and documentation for traceability.
- Responsible for Preparation of Job Responsibilities of new joinees.
- Responsible for Preparation of Department Matrix, Training calendar.
- Responsible for issuance of revised SOPS, retrieval and destruction of old version.
- Responsible for Qualification of Software
- Responsible for Preparations IQ, OQ and PQ Protocols and Report.
Education
Master of Science - Engineering Physics
Msc Engineering Physics
India 04.2014 - 06.2019
M.sc Management with Data Analytics - Business & Data Analytics
BPP University
London 03.2025 -
Skills
- Knowledge of regulatory standards
- Quality consciousness
- Software testing proficiency
- Auditing techniques
- Quality control tools usage
- Participated in USFDA, MHRA and EU audits
- Business analysis techniques
- Data analysis tools
- Microsoft Excel
- Power Point
- MS Word
Languages
English
Fluent
Timeline
M.sc Management with Data Analytics - Business & Data Analytics
BPP University
03.2025 -
Quality Assurance Executive
Acme Formulation Pvt. Ltd.
02.2022 - 02.2025
Quality assurance officer
Indoco Remedies Ltd.
09.2019 - 02.2022
Master of Science - Engineering Physics
Msc Engineering Physics
04.2014 - 06.2019
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