HM

Hazel Marquez

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Letztes Update: 18.12.2022

QA and QC Manager, Validation and Stability Officer, Analytical Development & Stability Officer

Abschluss: BS Chemistry
Stunden-/Tagessatz: anzeigen
Sprachkenntnisse: englisch (gut)

Schlagwörter

Analytisches Denken 21 Cfr Data Analysis Chemie Audits Datenverarbeitung Datenintegrität Folgenabschätzung Problemanalyse Kaufprozess + 6 weitere Schlagwörter anzeigen

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htmarquez_cv.docx

Skills

Verbal and written communication   skills 
Results interpretation/ Data Analysis
Data Handling
Data Integrity (application of 21 CFR part 11)
MS Office (Excel, Word, Powerpoint)
Problem resolution/Root Cause Analysis
Risk and Impact Assessment Supervision/ Leadership 
Project Management 
Analytical Method Validation, Equipment Qualification, Computer System Validation Process   Improvement
Internal Audits
Operational improvement
Laboratory equipment calibration 
Batch record analysis
Basic Chemistry
Equipment management Analytical Analysis
Instrument Calibration 
Purchasing Coordination Specification development

Projekthistorie

04/2022 - 12/2022
Product Development and Calibration Manager
Numan Food Supplement Corporation

Develop and formulate new products. Manage equipment calibration of the plant and ensure all the
regulatory requirements are compliant.

07/2021 - 01/2022
QA and QC Manager
East Asia Laboratories, Inc

Plan and direct the Quality Assurance / Control program. Designed to ensure continuous production of
products consistent with established standards. Planned, promote, and organize training programs
related to the company's Quality System.

Accomplishments
* Implemented Change Control, Risk Assessment, and Deviation Management
* Improved Documentation and Process Management of the site
* Established QMS requirements and KPIs
* Introduced Validation requirements (Computer System, Process and Cleaning Validation.
Introduction of MACO computation)
* Conducted QMS training (Principles and implementation) for different departments

01/2021 - 06/2021
Validation and Stability Officer
Glaxosmithkline

Ensure the implementation of validation-related commitments and stability programs of the site by
providing strategic plans that lead to 100% compliance.

Accomplishments
* Achieved 100% CTP of Decommissioning Plan
* Lead in Stability Transfer Project
* Achieved 100% CTP in Site Validation Master Plan (Process and Cleaning Validation, Analytical
Method Validation, Spreadsheet and Computer System Validation, Periodic Reviews)
* Supported QA in Internal Audits (LOC Audit conducted for 3 days)

06/2019 - 12/2020
Analytical Development & Stability Officer
Glaxosmithkline

Support the QC team in ensuring that all analytical methods and laboratory equipment are in a
validated state. Ensure that all analytical methods and their specifications are aligned with
regulatory requirements. Manage the Stability Program of the site and ensure that team's compliance
is within lead-time requirements

Accomplishments:
* Validated the remaining 25% of analytical methods of the QC Laboratory
* Conducted and supported computer system, process, and cleaning validation of the site
* Created and validated analytical methods for all marker compounds
* Qualified the newly purchased equipment in 1 month
* Validated spreadsheets (excel sheets) for QC Laboratory analysis computations
* Conducted training for the QC Analysts to improve their capabilities.
* Implemented process in proper glassware and HPLC Column Washing which leads to 20% OOS reduction
* Led deviation management concerning analytical methods and equipment qualification
* Active team member of the Validation Working Party
* Governed team's CAPAs, SOP revisions, risk assessments, deviations, and Change Controls. 95-100%
compliance every month.
* Received an award for collaborating with the technical team to deliver the NPI (new product) on
time (Global Employee Recognition for Teamwork)
* Received an award for requalifying equipment in 1 week (Global Employee Recognition for
Accountability)
* Received an award for the commitment to patients and consumers despite the Pandemic (Global
Employee Recognition for Accountability)
* Received an award for conducting Project Management training at the site (Global Employee
Recognition for Development)
* Received an award for providing strong support to LOC IBM
(Global Employee Recognition for Teamwork)
* Received an award for validating a complex method that is urgently needed by the site. (Global
Employee Recognition for Innovation)

07/2017 - 05/2019
Analytical Development Support
Glaxosmithkline


Support the QC team in ensuring that all analytical methods and laboratory equipment are in a
validated state. Ensure that all analytical methods and their specifications are aligned with
regulatory requirements

Accomplishments
* Validated 75% of analytical methods (including methods for cleaning) and equipment
* Achieved 100% CTP in Validation Periodic Review
* Governed team's CAPAs, SOP revisions, risk assessments, deviations, and Change Controls. 95-100%
compliance every month.
* Supported the QC Laboratory in L3 and L4 audits which resulted in a successful audit (Global
Employee Recognition for Teamwork)
* An active member of the Product Lifecycle team and awarded for teamwork in the improvement of PLM
(Global Employee Recognition for Innovation)
* Achieved 100% CTP in SOP and monographs/methodology review

08/2009 - 07/2017
QC Analyst

Responsible for testing raw materials and finished goods using analytical equipment and wet
analysis.

Accomplishments:
* Coordinated and performed analytical tests to comply with established standards and
specifications.
* Maintained an organized, safe, and efficient laboratory environment to minimize accidents and
prevent cross-contamination.
* Repaired, calibrated, and safely operated laboratory equipment to reduce costly instrument
downtime.
* Backed up Microbiologist for one month while searching for a full-time Microbiologist.
* Reduced backlogs in Stability Program by checking spreadsheets as per the plan

Reisebereitschaft

Verfügbar in den Ländern Philippinen
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