Cindy-joy Thomas

Experience

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  Dublin City Council

  Jun 2019 - Dec 2019

  Quality Control Analyst

  • Familiarized myself with GMP’s and GLP’s as well as the use of PPE.• Calibrated instrumentation and updated test/instrument specific log books daily as well as inputting sample information and/or test results into LIMS or Empower.• Performed various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods and ensure compliance with established standards.• Conducted and validated various biological and chemical quality control (QC) assays and control automated workflows and equipment. Show less

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  Takeda

  Oct 2020 - Sept 2021

  Quality Control Analyst

  • Responsible for conducting routine testing on solid oral dosage products.• Performed analytical testing such as Loss on Drying, Ultraviolet Identification, Thin-Layer ChromatographyIdentification, Dissolution testing (manual and automated), Assay Testing and Content UniformityAnalysis.• One of the few analysts trained on Related Substances analysis due to the complexity of this test.• Skilful in the use of High-Performance Liquid Chromatography systems and UV-Vis Spectrophotometer.• Work with team leads and quality analysts to participate in OOS/OOT investigations.• Highly Proficient in the use of LIMS, Empower, ThermoVision, Trackwise and SAP Ariba software• Conducts daily and weekly calibrations of instruments such as analytical balances and pH meters.• Responsible for purchasing/receiving laboratory consumables and ensuring that these are kept at theoptimum stock levels.• Provide training to new and existing QC analysts on all relevant laboratory procedures and analyses inaccodance with GMP and GLP.• Partake in AGILE projects related to the optimization of testing times for various tests and acceleration of sample release from the lab. Show less

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  ARKRAY,Inc.

  Sept 2021 - Jun 2022

  Quality Assurance and Regulatory Affairs Specialist

  responsible for overseeing final outgoing inspection of products to ensure compliance to specifications.Carrying out In process inspections to monitor performance of materials.Process patrol of production operations to monitor performance of materials.Conducting internal and supplier audits as required under ISO 13485.writing and revising procedures,records, IQ, PQ, protocols and checklists. Manage NCR’s and CAPA’s as required

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  Baxter International Inc.

  Jun 2022 - Jan 2023

  Quality System Specialist

  SME for NCR and CAPA process, responsible for driving completion of records on time, organising workshops and generating metrics for management review.• Hosting monthly Quality management review for multiple sites, gathering metrics and data from area owners of all departments and communicating KPI performance.• Responsible for documentation management on site. Issuance of working copies, logbooks and forms for all departments as well as reconciliation of data.• Reponisble for tracking the completion of periodic review of documents for all departments.• Assisting as required in completion of change controls, performing quality impact assessments and riskassessments.• Taking on supplier quality lifecycle management roles as required such as risk assessment mitigationrecords and SCARs, driving all child actions to completion and ensuring adequate responses are received from suppliers in a timely manner. Communicating any records that require escalation to the supplier quality review board and management.• Participating in internal and corporate audits as a Co-Auditor , auditing to ISO 134585, ISO9001, EU GMP Vol. 4, Eudralex and FDA Regulations.• Creation of audit checklists, audit programmes and the final audit report.• Participating in FMEA workshops and tracking actions arising from risk assessments for completion.• Authoring, updating/revising SOPs in response to audit observations and/or at the request of Quality management Show less

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  Alexion Pharmaceuticals, Inc.

  Jan 2023 - Apr 2024

  Quality Assurance Specialist

  • Provide Quality input, oversight and guidance to deviations and investigations to ensure robust rootcause analysis/CAPA definition and timely closure as per internal SOPs and QMS requirements.• Generation and reporting of quality metrics on a weekly, monthly, and quarterly basis.• Review and approval of functional area documentation (SOPs, Work Instructions, technical reports,and protocols)• Participate in quality risk assessments and provide quality oversight to ensure quality riskassessments are effectively maintained/ controlled.• Author, Review and Approval of Supplier Quality Agreements.• Leading actions assigned to site from complaints process• Provide support and expertise for inspection readiness activities, during health authority inspectionsincluding interaction with inspectors, responses to inspection observations, to monitor progress offollow up actions. Show less

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  Zimmer Biomet

  Apr 2024 - now

  Quality Engineer

  * Perform root cause investigations to drive product improvement and quality.* Write medical device and vigilance reports to competent authorities and notified bodies.* Formulate procedures, specifications, and standards for products and processes.* Investigate product complaints, record and manage complaint data in internal system and ensure timely and robust complaint record closure.* Develop and implement corrective/ preventative action plans.