Jasmin Tan

Key Responsibilities:

• Ensure that equipment decommissions are completed on time.
• Responsible for method transfer to sister site.
• Responsible for analytical documentation archival

Key Responsibilities:

• Perform resources planning, priority setting, and execution of activities to support shipment requirement.
• Review and release of QC testing results (Active Pharmaceutical Ingredients, Raw Materials, Tankers and packaging samples).
• Author for Analytical Method, Specification, Standard Operating Procedure (SOP), Work Instruction (WI) and Change Control.
• Conducted root cause analyses on out-of-specification results, identifying corrective actions necessary to address any issues promptly.
• Performed gap analysis against Analytical Technical Standard (ATS) and Pharmacopeia.
• Implemented process improvements that enhanced laboratory efficiency and reduced turnaround times for analyses.
• Performed quarterly trend review for defects, operational and equipment failure events of Analytical Laboratory system data.
• Subject Matter Expert for Stability Management, Reference Standard Management, Retain Sample Management, Out of Specification, Release of Raw Material and Products and SAP.
• Preparation for site audits by internal functions and external regulatory agencies to ensure GMP and regulatory compliance.
• Trained junior chemists on best practices in laboratory techniques and troubleshooting.
• Trained new joiners for laboratory related SAP module and provide data change in SAP.
• Collaborated with Analytical Development team to troubleshoot analytical issues and optimize analytical method robustness.
• Conducted internal audit to ensure laboratory is in compliance with GMP and Data Integrity.
• Supported periodic laboratory EHS Risk Assessment review and supporting or leading safety initiatives.
• Stand in for the QC Manager in her absence.
• Coach and mentor Analyst.

Key Responsibilities:

• Troubleshooted and improved existing analytical methods.
• Performed timely review of new or revised Pharmacopeia monograph to identify and address compliance gap.
• Assessed impact to the current analytical methods and specification due to new or revised monograph.
• Provided timely response to Regulatory Question.
• Revised Analytical Method, Quality Standard and Operating Procedure (SOP).
• Prepared for HSA audit & other audits.

Key Responsibilities:

• Supervised & lead a team of technicians that consistently achieved release of product within production targets
• Overall in charge of resource planning
• Reviewed Analytical data & tablet release & release product
• Product Review for laboratory data & perform trend analysis on the data.
• Provided support for registration and launch schedule by supplying CMC with CoAs and other information required for registration.
• Provided training for new staff.
• Lead and Conduct Laboratory Investigation for Out-of -Specification/ Atypical results.
• Revised Quality Standards, Standard Operating Procedure (SOP) & Standard Analytical Methods (SAM).
• Prepared for HSA audit & other regulatory audits.

Key Responsibilities:

• Performed product assays, purities & impurities finished products and stability sample in compliance to QC SOP, cGMP using HPLC and GC.
• Overall in charge & maintained smooth execution of stability programs.
• Reviewed of datasheets & Analytical Report Sheet (ARS).
• Prepared Monthly Stability Reports & Annual Product Evaluation Report – Stability.
• Conducted Laboratory Investigation (LIR) & Manufacturing Investigation (MIR).
• Developed & revised Testing Standards, Standard Operating Procedure (SOP) & Standard Analytical Methods (SAM).
• Preparation for HSA audit & other audits.
• Overall in charge of Analytical Balances & Karl Fischer Titrators in the laboratory.