Hellen Wu Email & Phone Number

Markham, ON, CA

Bramton, Ontario, Canada

• Planned and prioritized assigned document review workload to meet the requirement.
• Ensure that related documents for stability, calibration and analytical development and method validation are reviewed to meet Taro and cGMP requirements.
• Review OOT/OOS investigations and assist in establishing the root cause.
• Created, reviewed, and wrote SOPs pertaining to the group.
• Completed all GMP Documentation correctly and all training assignments.

Whitby, Ontario, Canada

• Reviewed all R&D group regular technical documents and confirmed data integrity. (e.g., Batch Record, RM, FP, method validation, development and transfer, stability study testing, calibration report).
• Reviewed and approved revised change control, SOP, GMP documents, method, and protocols.
• Provided technical support and assisted QMS and computerized system with daily operations.
• Conducted and reviewed OOS/OOT/DRs investigation generated by laboratory.
• Released Product Certificate of Analysis using LIMS and Raw Material & Packaging Components in SAP.
• Ensured the test method, protocols and SOPs have been followed by scientist/chemist in compliance with regulatory and global quality policies.

Pickering, Ontario, Canada

• Improved outputs in document review including lab notebooks, analytical data, batch records, validation documents and instrument calibration certificates to ensure compliance with the regulations.
• Reviewed product release documents to verify completeness, correctness, and accuracy.
• Conducted lab related work is documented in compliance with date integrity.
• Regularly inspected in production process control and package online check.
• Standardized SOPs, optimized test methods, updated specifications and followed validation protocols through continuous improvement activities.
• Tracked and identified OOS / OOT results, deviations, atypical results, or any issues of non-conformance and carried out investigations.

Pickering, Ontario, Canada

• Significantly improved skill metrics level in the department with through capability and contribution of analyzing raw materials, in-process /finish products, stability, and method validation/development.
• Completed a few projects which required method validations and successfully transfer to product.
• Efficiently operated, calibrated, maintained laboratory instruments to warranty their accuracy and utilization such as HPLC, GC, FTIR, Vis-UV, ICP, dissolution apparatus, auto-titrator, etc.
• Documented comprehensive, accurate and timely experimental observations.
• Provided techniques and problem-solving solutions that support troubleshooting complex instrumentation and method problems

Mississauga, Ontario, Canada

• Analyzed different dosage form samples in full testing, including identification, dissolution, water determination, assay, content uniformity, purity, related substance, residual solvent, wet chemistry and physical.
• Interprets and documents all test results, calculation, and observation.
• Interact with R&D group on method development and validation.
• Cooperated proactively with team members on multiple projects and met tight deadlines.