Summary
Overview
Work History
Education
Skills
Licensure Examination Passed
Applicant Signature
Position Desired
Timeline
Generic
SARAH TAGUBA

SARAH TAGUBA

Chemist

Summary

Experienced Team Leader/Laboratory Supervisor with 10+ years of experience in leading laboratory operations and personnel. Skilled in data analysis, problem-solving and quality control. Expert in Method Transfer, Dissolution Profile, Method Validation/Verification, Process Validation and Cleaning Validation.

Organized Team Leader builds positive rapport, inspire trust and guide teams toward achievement of organizational goals. Strong facilitator adept at working cross-departmentally with co-management and top-level leadership. Excellent trainer and mentor.

Overview

22
22
years of professional experience

Work History

Stability Team Leader - Analytical and Research Development

Hizon Laboratories, Inc
10.2019 - 02.2024
  • Conducted training , mentored and guided analysts to foster proper completion of assigned duties.
  • Established open and professional relationships with team members to achieve quick resolutions for various issues.
  • Scheduled analytical method validation and process validation activities as per the regulatory requirements
  • Scheduled analysis of new formulated drug products
  • Checked and verified raw data submitted by the analysts for its completeness, compliance and traceability before releasing of results
  • Reviewed and checked the feasibility of test procedure for the current laboratory setup
  • Performed troubleshooting related to test method and designs additional experimentation if necessary
  • Prepared and reviewed analytical protocols and reports (Analytical Method Validation - Assay, Analytical Method Validation – Organic Impurities, Cleaning Method Validation – Residue Recovery, etc)
  • Prepared and reviewed Standard Operating Procedures (SOP) and Test Method
  • Involved in the investigations during incidents/deviations/change controls, out-of specifications, and complaints
  • Ensured compliance as per regulatory requirements of GLP and cGMP.

Stability Team Leader - Dissolution

Hizon Laboratories, Inc
04.2014 - 09.2019
  • Conducted training and mentored analysts to promote productivity, and accuracy of laboratory resuts
  • Scheduled dissolution profile analysis for products undergoing development studies and for compliance to FDA requirements
  • Scheduled dissolution validation/verification
  • Checked dissolution tests reports and provides on time review of dissolution and dissolution profile results
  • Prepared protocol and reports for dissolution profile analysis
  • Monitored calibration schedule of dissolution apparatus
  • Performed troubleshooting of minor problems on analytical instruments
  • Acted as Laboratory Operations Team Leader (Supervisor) – FG Testing in her absence

Quality Control Analyst

Knoll Ridges Consultancy for GlaxoSmithKline
04.2013 - 03.2014
  • Conducted routine and non-routine analysis of Raw Materials, In-process, and Finished Products according to Standard Operating Procedure
  • Prepared and standardized volumetric and test solutions
  • Performed chemical analysis on rinse water samples to ascertain effectiveness of cleaning process conducted on the processing equipment
  • Ensured proper documentation of raw data in the Analytical Report
  • Attended SOP Training/seminars and participated in the department's staff meeting and technical discussions
  • Practiced safe work habits and adhere to company's safety procedures and guidelines
  • Performed other duties as required by immediate supervisor.

Quality & Technical Assurance Engineer

SCC Innovasia
10.2012 - 01.2013
  • Monitored day-to-day production activities and ensures that the handled production lines conforms to cGMP and FDA regulations
  • Ensured that all the released products conformed to the client's finished product specifications
  • Trained the production staff in updated work instructions and procedures
  • Supported the Q&TA Inspectors to ensure that products and processes comply with the relevant requirements of the quality management system
  • Worked with Manufacturing to solve in-house quality concerns, reviewed non-conforming products and recommended disposition
  • Handled consumer complaints, initiated investigations and made reports
  • Conducted investigations on non-conformances and recommended Corrective and Preventive Actions
  • Conducted audits, including closing out audit findings, prepared audit findings reports to determine the proper corrective and preventive actions
  • Assisted the Q&TA Manager in establishing, implementing and maintaining the quality management system
  • Participated in monthly Quality Council, Quality Steering and Monthly Operations Performance Report
  • Participated in Quarterly Supplier's Performance Audit.

Stability Team Leader – FG Testing

Hizon Laboratories, Inc
11.2008 - 06.2012
  • Trained, mentored and guided employees to foster proper completion of assigned duties while maintaining the accuracy of results
  • Scheduled daily assignment of all analysts
  • Checked results and computations of analytical reports and protocols submitted by the analysts
  • Ensured that all of the commercial and new products undergoing stability studies are tested on time
  • Investigated Out of Specifications (OOS) Report submitted by the analysts and performs immediate corrective action
  • Conducted performance appraisal of analysts
  • Prepared the Daily Accomplishment Report of the Stability Analysts which will be submitted to the Stability Manager
  • Coordinated with the Stability Manager in preparing the Monthly Status of Stability Department
  • Coordinated with the Formulation Department regarding the test schedule of incoming new products
  • Ensured that the new analytical procedures supplied by the client is feasible and coordinates with the Stability Manager regarding the status of analysis
  • Ensured adequate inventory of reagent and laboratory supplies
  • Performed troubleshooting of minor problems on analytical instruments
  • Ensured that the Preventive Maintenance of all HPLC instruments were performed on time


Stability Analyst

Hizon Laboratories, Inc
08.2003 - 10.2008
  • Acted as an OIC, in the absence of the Stability Supervisor and conducted its assigned duties such as giving the assignment to the analysts, coordinates with the department manager regarding the status of the stability studies, inventory of the USP and House standards, et al
  • Examined the feasibility of analytical test methods
  • Monitored availability of reagents/reference standards and informed the supervisor of materials due for requisition
  • Assisted new Stability analysts in performing various analysis as instructed by the Stability Supervisor
  • Performed analysis (physical testing, dissolution, assay and identification) on new products and on samples that undergo stability testing using the official laboratory procedures (USP/BP/PP)
  • Prepared and standardized volumetric and test solutions
  • Conducted Dissolution Profile on drug samples and prepares summary report prior to BFAD registration
  • Conducted Method Validation/Assay Validation (HPLC and chemical procedures), Cleaning Validation and Process Validation
  • Validated House Standard (HPLC and Potentiometric Titration method) for the laboratory use
  • Performed Column Efficiency on HPLC columns to ensure its efficiency in the future use
  • Calibrated simple laboratory instruments or equipment
  • Attended SOP Training/seminars and participates in the department's staff meeting and technical discussions
  • Ensured that the working area including the laboratory apparatus safe and clean by strict compliance to Good Laboratory Practices.

Laboratory Analyst/Permitee

Aeronics, Incorporated
05.2002 - 07.2003
  • Conducted wastewater analysis on various parameters
  • Prepared/standardized volumetric and test solutions
  • Participated in Laboratory Proficiency Testing by the DENR
  • Supervised the commissioning and monitoring of Wastewater Treatment Plant (WWTP), Oily Wastewater Treatment System (OWTS), and Sewage Treatment Plant (STP)
  • Conducted simulation and jar testing on the wastewater influent sample as a basis of design for WWTP
  • Attended seminars/trainings and participates in the department's and company's staff meeting
  • Prepared monitoring results prior to the requirements under Environmental Monitoring Plan (EMP) of Environmental Compliance Certificate (ECC) for the clients
  • Acted as an environmental consultant on the environmental issues and problems particularly on the permit conditions of the various clients.

Education

Bachelor of Science - Chemistry

Polytechnic University of The Philippines
Sta. Mesa, Manila, Philippines
04.2001 - 05.2001

High School Diploma -

Our Lady of Peace School
Antipolo City
04.2001 -

Skills

    Quality Improvement

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Licensure Examination Passed

Licensure Examination for Chemists

Applicant Signature

SARAH G. TAGUBA

Position Desired

Chemist/QC Supervisor/QC Manager/Laboratory Head

Timeline

Stability Team Leader - Analytical and Research Development

Hizon Laboratories, Inc
10.2019 - 02.2024

Stability Team Leader - Dissolution

Hizon Laboratories, Inc
04.2014 - 09.2019

Quality Control Analyst

Knoll Ridges Consultancy for GlaxoSmithKline
04.2013 - 03.2014

Quality & Technical Assurance Engineer

SCC Innovasia
10.2012 - 01.2013

Stability Team Leader – FG Testing

Hizon Laboratories, Inc
11.2008 - 06.2012

Stability Analyst

Hizon Laboratories, Inc
08.2003 - 10.2008

Laboratory Analyst/Permitee

Aeronics, Incorporated
05.2002 - 07.2003

Bachelor of Science - Chemistry

Polytechnic University of The Philippines
04.2001 - 05.2001

High School Diploma -

Our Lady of Peace School
04.2001 -
SARAH TAGUBAChemist