Sr. QA Coordinator: GMP QMS & Compliance

Tania Kuba

Sr. Coordinator Quality Assurance

P: 647-***-**** E: ***********@*****.*** LinkedIn: https://www.linkedin.com/in/taniakuba/ SUMMARY

Quality Assurance professional with 5+ years of experience supporting GMP-regulated pharmaceutical industry. Proven expertise in high volume document control, change management, and Quality Management System (QMS) including support for Health Canada and FDA inspection readiness. Experience in reviewing and maintaining thousands of GMP-controlled documents monthly, exciting change controls, supporting investigations (CAPA, OOS, deviations) and driving continuous improvement initiative. Detail oriented, collaborative, and effective in fast paced highly regulated settings. SKILLS

Corrective Action Preventative Action (CAPA) Data Evaluation GMP/cGMP/GDP Root Cause Analysis Risk Mitigation Quality Management System

(QMS) Investigative Procedures Deviation Management Regulatory Compliance Health Canada/FDA Audits Out of Specifications (OOS) Product Quarantine/Release

EXPERIENCE

SUN PHARMA, Brampton, ON Sr. Coordinator Quality Assurance Sep 2025- Present

• Lead high volume document control activities, reviewing, revising, and updating 100+ GMP controlled documents per week as part of rebranding and redemption initiative.

• Execute and manage change control processes, to ensure compliance with GMP, cGMP and Quality Management System (QMS) requirements while maintaining data integrity and version control.

• Collaborate with corporate Quality Assurance and cross functional teams to maintain Health Canada inspection readiness ensuring accurate, current and traceable documentation.

• Coordinate timely implementation of documentation changes across multiple departments, maintaining audit traceability in fast paced regulated industry.

• Identify documentation gaps and standardize templates, supporting continuous improvement and reducing rework during document review. IOVATE, Oakville, ON Quality System Technician Apr 2025 - Jul 2025

• Supported the Stability Program by coordinating samples with third-party labs, evaluating test results, and generating summary reports in compliance with Health Canada and FDA regulations.

• Initiated and documented investigations into recurring complaints, OOS results, and deviations, strengthening the Quality Management System

(QMS).

• Managed product quality complaints and counterfeit inquiries, enhancing product integrity thorough tracking and investigation.

• Drafted, reviewed, and updated SOPs and work instructions to improve regulatory compliance and streamline operations.

• Performed in-house identification (ID) testing on products to confirm compliance with specifications and regulatory requirements.

• Reviewed product artwork and labeling to ensure compliance with IOVATE guidelines and Canadian regulatory standards. Grifols, Hamilton, ON Quality System Associate Feb 2025 - Apr 2025

• Ensured compliance with GMP and Health Canada regulations by supporting the creation, review, and implementation of SOPs, reports, and controlled documentation.

• Collected and analyzed data for trend analysis, driving improvements in quality control measures and operational efficiency.

• Conducted internal audits and supported external audits to ensure compliance with GMP requirements.

• Tracked deviations and nonconformities, managing corrective and preventive action (CAPA) plans to resolve issues effectively.

• Reviewed and revised controlled documents while overseeing change control processes to maintain regulatory compliance.

• Ensured accurate equipment validation, calibration, and preventive maintenance to maintain consistent product quality and regulatory compliance.

• Monitored Environmental Excursion Systems to identify and mitigate risks, supporting a safe and controlled manufacturing environment.

• Delivered GMP training sessions to staff, strengthening compliance awareness and fostering a culture of continuous quality improvement. Pancap Pharma Inc., Markham, ON QA Specialist Mar 2022 - Jan 2025

• Ensured compliance with GMP, GLP, Health Canada, FDA, and USP regulations, enhancing product conformity and documentation accuracy.

• Produced, interpreted, and approved reports while tracking stability samples and reviewing batch documentation in line with SOPs.

• Drafted and maintained SOPs, protocols, work instructions, and technical reports; conducted instrument calibrations to ensure accuracy.

• Performed chemical and instrumental analyses including UV, IR, pH meter, wet chemistry, LOD, and HPLC to support product quality.

• Tested and monitored product labels to meet regulatory and compliance requirements.

• Experienced in CAPA, OOT/OOS investigations, QMS processes, compliance audits, and process development.

• Trained and mentored new analysts, reinforcing adherence to quality standards and regulatory expectations. Academy of Applied Pharmaceutical Sciences (AAPS), Toronto, ON Pharmaceutical QAQC - In Training Jan 2021 - Jan 2022

• Conducted spectrophotometric identification tests (HPLC, UV-VIS, FT-IR), TOC, and sieve analyses on raw materials and finished products in compliance with USP and in-house methods.

• Performed analytical method validation and system suitability testing (SST) for HPLC to ensure accuracy and reliability.

• Prepared sample and standard solutions, performed pipette calibration, and managed laboratory equipment calibration programs.

• Documented raw data and analytical results in accordance with SOPs, GMP, GDP (ALCOA), and USP requirements.

• Trained in GMP/cGMP principles, including QMS, risk management, QC, auditing, OOS/OOT investigation, recall, complaint handling, and stability testing.

Process Research Ortech Inc., Mississauga, ON Chemical Engineer Jun 2017 - Dec 2019

• Conducted IC, ICP-OES, and ICP-MS testing for trace metals detection, along with XRF, dilution, fusion, and organic carbon analyses to ensure accurate results.

• Prepared material and heat balance calculations to support smelting furnace operations and process optimization.

• Applied standardized formulas to conduct experiments, tests, and analyses in compliance with quality and safety standards.

• Developed sampling protocols and analysis data to monitor processes and maintain quality standards. EDUCATION

Academy of Applied Pharmaceutical Sciences (AAPS), Toronto, ON Post Graduate Diploma in Pharmaceutical Industry (QAQC) GMP (Jan 2021 - Mar 2021), Auditing (Feb 2021 - Mar 2021), Technical Writing (Feb 2021 - Mar 2021)

University Malaysia Pahang (UMP), Malaysia

Master of Science (MSc.) in Chemical Engineering

IT PROFICIENCY

MS Office (Excel, Word, Outlook, PowerPoint - Advanced) MasterControl (Advanced) Power BI

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