Experience

Wooshin Lapache

• Slovenia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Control Specialist

  • Jan 2022 - Present

   Performing all quality analysis for Transdermal patches (TDDS) and oral Disintegrating films (ODFs).  Performing analysis of Finished Products, In process, Raw materials samples and stability samples.  Handling of HPLC, GC, Dissolution KF, UV and IR instruments.  Handling of LabSolutions software and integration of chromatograms.  Preparation of standard operating procedure, Standard testing procedures and specifications for finished products and raw materials.  Performing Calibrations HPLC, GC, Dissolution KF, UV, IR and other Quality control instruments.  Preparing monthly checks for qualifications, calibration and maintenance for Quality control instruments. .  Handling of Quality management system (QMS) part investigations on analytical techniques in quality control department like out of specification (OOS), out of trend (OOT), Laboratory deviations and Corrective action and preventive action (CAPA).  Preparation of Method Validation protocols and Reports as per ICH Q2 R1 and (R2).  Review of Analytical reports and results.  Preparation Certificate of analysis (COAs) for finished products, stability products, raw materials, In- Process and Packing materials.  Verifying the stock of chemicals, Standards and ordering chemicals and pharmaceutical standards and impurities.  Preparation of stability protocols and Reports to meet different climatic zones (Accelerated ,Long term and Long term Zone IVB).  Performing microbiology analysis for transdermal patches and purified water.  Performing Growth promotion test for microbiology media (Solid Media and Liquid Media).  Preparation of method verification protocols and analytical raw data as per respective monographs. Show less



Granules India Limited

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Control Executive

  • Jan 2020 - Jan 2022

   Performed analysis for Oral Solid dosage forms and pre formulation granules.  Processing of Chromatograms in EMPOWER 3 software (Related Substances, Assay, Dissolution and Uniformity dosage forms.  Validation of custom field calculations in EMPOWER 3 software like Assay, Content Uniformity, Blend Uniformity, Dissolution single points, Dissolution profiles and Related substances.  Initiation of forms for Out of specification (OOS), out of trend (OOT) ,Manual reprocessing chromatogram (MRC) and Laboratory deviation report.  Performed Method validations, Method verifications and method transfers.  Regular and retest batch analysis by HPLC Related substances and Assay Finished Products, Stability Products. (Oral Solid Dosage Forms), Dissolution by HPLC, In-process samples and Blend uniformity by HPLC.  Performed processing and documentation of Related substances by HPLC with custom field calculations and manual validated excel calculations.  Performed Freeze thaw study analysis. Show less



MSN Laboratories

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Control Executive

  • Aug 2016 - Dec 2019

   Performed analysis for Oral Solid dosage forms and injectables.  Performed the calibrations instruments like HPLC, GC, Analytical Weighing balances pH Meter, Polarimeter and Refractive index etc.  Performed Method validations, Method verifications and method transfers. (HPLC, PXRD and ICPMS).  Processing of Chromatograms in EMPOWER 3 software.  Preparation of SOP, Specification and Standard testing procedure.  Regular batch analysis of PXRD and ICP-MS (Both Drug substances and Drug Products) Finished Products, Stability, Excipients & Raw materials.  Handling of Change control Forms Notifications, Nominations, Incidents, OOS and CAPA.  Method Development and Method Validation of Elemental Impurities in different drug substances and drug products per ICH Q3D guidelines by using ICP-MS.  Performed Method validations, Method verifications and method transfers.  Receiving of samples and allotting the analytical reference number. Show less