Driven Quality Assurance professional with a proven track record at Baxter Healthcares, enhancing product quality by implementing rigorous inspection processes and fostering team collaboration. Expert in Batch Cards, Process Validation and adept at problem-solving, significantly reduced defect rates. Passionate about maintaining high standards and achieving company-wide safety goals through meticulous attention to detail and reliability.
Overview
4
4
years of professional experience
Work History
Quality Assurance Associate
Zifam Pinnacle Pvt Ltd.
Smithfield, NSW
10.2023 - Current
Perform In-process Quality Control of the intermediate product at all stages and report to Quality Manager if any Out of Specification (OOS) observed different than mentioned in Batch Manufacturing Record.
Checking and preparation of the release of different stages of the intermediate product i.e., blending, compression, coating, and packaging.
Record keeping of the entire lifecycle of the production including the Batch Manufacturing Record issuing including reconciliation of the batch card as well as trending of it.
Assist in the carrying out internal audits for the quality assurance purposes.
Handling of quality documentation including deviations, Change Control, Risk Assessments, and Root Cause Analysis.
Maintenance of logbooks, calibration, and maintenance records for all GMP equipments Coordinate with Production department, commercial, warehouse department during all stages of production and dispatch of the finished good materials for the distribution.
Perform the investigation of market complain of the drugs relating to its manufacturing and packaging defects.
Assist in the routine preparation of product master instructions (Batch Manufacturing Record and Batch Packaging Record) and SOPs under professional guidance and supervision.
Strong and ethical implementation of Good Manufacturing Practice (GMP) , Good Laboratory Practice (GLP) and Good Documentation Practice.
Establishing, tracking, validating, and monitoring production performance.
Document all results accurately and efficiently including preparation of analytical reports, Release for sale and Certificate of Analysis.
Coordinate with Raw Material, QC laboratory, R&D, Artworks, Production, Packaging and Finished Goods department to ensure the quality and specification of the product.
Quality Assurance Officer
Baxter Healthcares
Toongabbie, NSW
01.2022 - 09.2023
Daily on-floor quality checks and oversee of production processes.
Giving line clearance at all the stages of packaging finished goods.
Maintaining Electronic Batch Document and Bill of Materials.
Development, implementation and maintenance of overall quality systems.
Investigation of customer complaints and non conformances.
Carried out pharmaceutical calculations at each stage of packaging of the product.
Strong and ethical implementation of Good Manufacturing Practice (GMP) , Good Laboratory Practice (GLP) and Good Documentation Practice.
Maintenance of logbooks, calibration, and maintenance records for all GMP equipment.
Assist in the carrying out internal audits for the quality assurance purposes.
Reduced defect rates through meticulous inspection processes and root cause analysis.
Quality Control Inspector
Hello Fresh Grocery Delivery E-Services
Eastern Creek, NSW
02.2021 - 01.2022
Communicated with production team members about quality issues.
Inspected quality of products, taking note of functionality, appearance and other specifications.
Inspected incoming and outgoing materials for accuracy and quality.
Reported repeated issues to supervisors and other departments, collaborating to identify issue roots and rectify problems.
Performed visual inspections and non-destructive tests where appropriate.
Evaluated components and final products against quality standards and manufacturing specifications.
Participated in team meetings to discuss progress and results, providing ideas and suggestions for improvement.
Reduced product rejection rates by collaborating with production teams to address quality issues proactively.
Actively participated in regular audits to verify compliance with industry regulations and company policies, ensuring continued certification and enhanced credibility within the market.
Enhanced production efficiency by implementing standardized inspection processes and procedures.
Trained and mentored junior inspection staff and interns to apply best practices and comply with quality control guidelines and regulations.
Played an integral role in achieving company-wide safety goals by diligently enforcing proper handling practices during all stages of the inspection process.
Increased customer trust by ensuring all product batches met stringent quality criteria before release.
Improved product quality by conducting thorough inspections and identifying defects in a timely manner.
Education
Masters Of Quality Analysis And Management - Quality Assurance
Macquarie University
Sydney, NSW
12.2020
Bachelors Of Pharmacy - Pharmaceuticals
Rayat-Bahra University
Mohali, India
07.2018
Skills
TGA specifications
Inspections
Validation Protocols
Batch Production Records
Problem-solving skills
Team Collaboration
Team Leadership
Decision-Making
Safety Procedures
Quality improvements
Analytical Thinking
Quality Management Systems
Documentation And Reporting
Quality Assurance
Attention to Detail
Multitasking
Reliability
Languages
English
Timeline
Quality Assurance Associate
Zifam Pinnacle Pvt Ltd.
10.2023 - Current
Quality Assurance Officer
Baxter Healthcares
01.2022 - 09.2023
Quality Control Inspector
Hello Fresh Grocery Delivery E-Services
02.2021 - 01.2022
Masters Of Quality Analysis And Management - Quality Assurance