Diah Setyaningtias

Experience

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  PT Kalbe Farma, Tbk

  Nov 2010 - Jan 2019

  Analytical development

  Develop and validate robust analytical method by applying QBD system, also reviewing finish and intermediate product and raw material specifications.Instrumentation capability, including :HPLC isocratic/gradient with UV-Vis/PDA/Refractive Index/Fluorescence/ELSD detector, UPLC, LC-MS/MS, Spectrophotometer order 0/1st derivate, AAS, GC, TLC, Particulate Size Analyzer, Karl fischer, IR Spectrophotometer, Auto titrator, dissolution tester, microbalance, pH meterDeveloping analytical method for various dosage form, including :Tablet (film/enteric coating), Capsule, Soft capsule (filling with oil/suspension), Injection (small/large volume), sachet powder, oral solution/suspension, creamDeveloping analytical method for reverse engineering, including :Surfactants, diluents, disintegrantsStability testing for new pharmaceutical formulation, including assay, impurity, dissolution, profile dissolution determination including study of determining discriminating medium dissolution for each BCS class. Handling drugs : amino acids, immuno-supressant, multivitamins and minerals, antiviral, cold and flu, anticoagulant, many supplements from animal and plant extracts.Ensuring delivery in accordance with project timescales and deadlines including purchasing, validating, maintaining equipment and also computer system validation (CSV) of EMPOWER ENTERPRISE for analytical development activities and controlling laboratory chemicals required for analytical development activities. Reviewing analytical report through LIMS, estimation expire date and perform analytical investigations and analytical problem solving, in support of formulation (RnD) activities. To supervise the day to day analytical development activities and analytical development team including motivating, coaching and mentoring the analytical development team.Understanding and developing practical GLP and GMP in laboratory, supporting PQ-WHO project. Show less

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  Landson PT Pertiwi Agung

  Feb 2019 - Mar 2020

  Analytical Development Asst. Manager

  As a key member of the Analytical Development team, provide support for Quality Control, Quality Assurance, Manufacturing and Regulatory departments. Plans and executes scientific experiments to achieve corporate goals for new product development also existing product development. Develop and validate new assay and techniques as required to support new product development.Meet project objectives within timelines and budgets.Oversee analytical method transfer to Quality Control.Scope of project :OTC, traditional drug, food supplement, ethical, export, toll in, toll out.Dosage form :Soft / hard capsules, cream & ointment, tablet / caplet, injection, dry syrup, liquid. Show less

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  PT Kalbe Farma, Tbk

  Mar 2020 - Jun 2024

  Analytical development
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  PT Ethica Industri Farmasi

  Jun 2024 - now

  R&D Project Dossier Compliance Manager