Vicky Ng Email & Phone Number

Bethlehem, Pa, Us

Perform review of GMP data generated by QC Chemistry, investigations, method validation protocols and reports. Laboratory Testing requests by other departments. Collaborate with QC management and QA to ensure data integrity, GDP, GMP requirements are met.• Perform analytical data (including HPLC/UPLC, GC, IC, UV, AA, KF, FT-IR, USP / EP / BP monographs), laboratory notebooks and audit trail review to ensure compliance to the approved in-house procedures for raw materials and finish products.• Review, approve and release raw materials in LIMS and SAP for product release.• Responsible for lab investigation review from OOS confirmation, investigation test plans to final results. Constantly communicate with QC managers and analysts to get progress update to support on-time CAPA closing and product release.• Review of analytical method validation, method transfer, USP method verification to support departmental growth.• Work closely with analysts and QC/QA managements to improve and address quality issues (OOS, OOT, deviations, audit trail and CAPA). Discovered reagent misuse during review due to unclear SOP procedures which requires method revisions. Contacted USP for method clarification to support on-time investigation closure.• Provide technical support to analysts during notebook review to accelerate the review process. Assist analysts with integration for raw material and finished product with about 30 impurity peaks for improving result accuracy.• Compile stability data for trending purposes. Notified and provided stability data to QC management for out of trend total impurity results. The problem was resolved by comparing historical purity results and found out there are integration inconsistency which leaded to OOT.• Perform logbook and audit trail review in regulated high-potency laboratory that required PPE gowning.• Participate in Operational Excellence projects.• Assist with monthly laboratory audit for GLP compliance.

Evaluated and assessed existing analytical test methods to ensure compliance in preparation for FDA audit and provided guidance in corrective actions.• Reviewed test methods, protocols and reports for method validation, verification, and transfer activities for solid dosage products to ensure compliance with SOPs, USP, cGMPs and ICH guidelines.• Performed risk and impact assessments for existing analytical test methods.• Wrote assessment reports for identified deviations and gaps. Provided guidance, recommendations and path forward activities to correct them. • Assisted with remediation processes including writing protocols for method validations.

Provided analytical support to QA and QC for product release and method transfer. Coordinated with laboratories both domestic and international to support method validation and transfer to ensure compliance to the quality systems • Assisted Manufacturing organization on investigation of various out of specification issues such as particulate matters, color and pH issues during production. Performed failure mode analysis for investigation on materials used during filling and packaging to find out the root cause and save 2 urgent production timelines.• Assisted quality organization on identifying failure on system suitability, low / high assay, impurities, and instrument optimization issues during batch testing for CAPA closing to support product release. • Coordinated method transfer, verification, and equivalency testing for more than 15 injectable products from internal, vendor and USP / EP analytical methods.• Reviewed method validation and transferred data from laboratories in Missouri, Croatia and Hungary. Participated in weekly teleconferences to solve laboratory-related problems encountered during method validation / transfer processes by cause and effect analysis. Suggested alternative sample preparation and instrumental techniques which lead to a successful validated method and transfer.• Wrote technical reports, protocols and memoranda on analytical method validations, USP / EP / BP method verifications, transfers and SOPs in compliance with cGMPs, ICH guidelines. Constantly communicating with USP method representatives to clarify on method procedures and highlighted mistakes that occurred in the monographs which required revision.• Guided and trained new scientists on technical-related issues and supported the manager in objective settings, performance evaluations and development planning discussions.

Identified and performed the analytical tasks for issues encountered in R&D, QC, and manufacturing. Provided internal / external customers with timely responses and useful information needed to reduce down time and gain trust in the department and products. • Investigated a problem regarding the failing of system suitability encountered by QC. Through reviewing related reports, data and re-testing, the problem was resolved and the product could be released. • Assisted in setting meaningful and achievable Corrective and Preventive Actions for investigations.• Assisted in documentation support during FDA audit to ensure the accuracy of the documents and provide to the auditor in a timely matter.• Provided a timely response to a customer regarding the physical properties (e.g. specific gravity) of a drug that was required to start a diagnostic process and resolve issues with a large batch of drug products they had stored incorrectly and whether they were in or out of effective range. Immediate laboratory support including specific gravity calculation and stress study were carried out within a short period of time to provide the customer with satisfactory results to save the customer’s time and cost.• Developed and reviewed analytical methods for drug, impurities, preservative, and excipient in finished products and raw material utilizing HPLC, GC and GC Headspace, IR, UV-Vis, and Karl Fisher.• Performed a presentation during a team department meeting regarding a recent accomplished project and analytical techniques obtained from seminars. Mono-aqua formation during analytical testing of an anticancer drug caused the failing of total impurities and UPLC techniques were presented to promote group learning.

Technical Services 2006 – 2009• Identified and analyzed potential problems and implemented contingency plans to overcome them. • Performed and coordinated raw material, finished product qualification test and analytical method transfer to support pilot manufacturing.• Utilized Laboratory / Manufacturing Software: Empower, Waters Millenium, Agilent Chemstation, Electronic Lab Notebook (ELN), LIMS, Oracle, and Trackwise.

Master Of Science (M.S.), Chemistry

Bachelor Of Science - Bs, Chemistry