Raheen Tabasssum

Detail-oriented and highly motivated pharmaceutical professional with a Master's degree in Pharmaceutical Analysis and over 2 years of hands-on experience in quality control and analytical testing within GMP-regulated environments. Currently working as a Product Builder at Medtronic in Galway, operating in a cleanroom environment and adhering to ISO 13485 Quality Management Systems and Good Manufacturing Practices. Skilled in operating analytical instruments such as HPLC, UV-Vis, with proficiency in data acquisition and reporting using Empower software.

Demonstrated ability to conduct routine and non-routine analysis of raw materials, in-process samples, and finished products while ensuring strict compliance with regulatory and quality standards. Experienced in managing laboratory inventory to ensure operational efficiency. Adept at learning new testing procedures and software quickly, contributing to increased productivity and reduced testing turnaround times.

Product Builder at Medtronic (2025-05 – Present)

• Assembled medical devices in a cleanroom environment in strict compliance with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP).
• Performed diverse production tasks on a rotational basis to enhance efficiency, reduce operational waste, and support team flexibility.
• Maintained rigorous quality control standards to ensure all finished products met precise specifications and regulatory requirements.
• Contributed to continuous improvement efforts by identifying process inefficiencies and providing actionable feedback to supervisors.
• Complied with all company health, safety, and environmental protocols to maintain a safe and compliant workplace.
• Demonstrated adaptability and a commitment to growth by actively engaging in training for new equipment and production processes.
• Supported team development by assisting in the onboarding and training of new Production Operators, depending on experience level.
• Adhering to Quality Management System (QMS) protocols aligned with ISO 13485 standards to ensure compliance with regulatory and operational requirements.

Quality Control Analyst at Chandra Labs (2022-02 – 2024-04)

• Operated and maintained HPLC and UPLC systems, ensuring accurate and precise analytical results
• Developed and validated analytical methods for quantifying pharmaceutical compounds, adhering to EMA and EU guidelines
• Performed both routine and specialized testing of raw materials, in-process samples, stability samples, and finished products using analytical techniques such as HPLC, UV-Vis, ensuring adherence to internal quality specifications and regulatory standards.
• Led stability testing for a product undergoing climate-controlled storage to simulate market conditions, validating the method's capability to consistently detect active ingredient degradation. Regularly monitored stability results and detected early degradation signs, prompting reformulation to improve product shelf-life
• Conducted analytical testing in alignment with GMP standards, ensuring data integrity and full traceability for regulatory approvals and product release.
• Maintained and calibrated analytical instruments such as HPLC and UV-Vis Spectrophotometer to boost testing precision and lab productivity. Accurate documentation practices contributed to a 15% drop in data recording errors and improved audit readiness.
• Supported the coordination and tracking of sample submissions, ensuring proper labeling procedures were followed, which led to a 10% decrease in sample identification errors and streamlined laboratory operations.
• Drafted and verified certificates of analysis for batch releases, ensuring compliance with regulatory standards and data accuracy.
• Detected and flagged minor discrepancies in analytical procedures, aiding early issue identification and contributing to timely quality corrections.
• Adapted quickly to new laboratory protocols, instrumentation, and software systems, enhancing testing throughput and contributing to improved team efficiency.
• Assisted senior analysts in investigating Out of Specification (OOS) and Out of Trend (OOT) results, compiling comprehensive reports
• Assisted in the identification and root cause analysis of laboratory deviations and non-conformances, contributing to CAPA documentation and follow-up.
• Collaborated with the QA team to verify traceability of results through proper logbook entries and audit-ready documentation, supporting regulatory readiness and GMP compliance.
• Participated in daily lab activities such as labeling, enhancing traceability and helping reduce workflow bottlenecks in the QC lab.
• Observed and learned how minor testing discrepancies are identified, documented, and resolved under guidance from senior chemists, gaining exposure to root cause analysis and deviation management.

Masters of Pharmacy in Pharmaceutical Analysis – India (2020 – 2022)

Bachelors of Pharmacy in Pharmacy – Vijay College of Pharmacy (2015 – 2019)