Dunia Salameh

Experience

• 

  Pharmacare PLC

  Jun 2011 - Sept 2021

  • Working on projects to effectively manage large amounts of data and working with IT and other labs to design efficient IT systems for the data, and maintaining data integrity through the data life cycle.• Reviewing lab data cycle including audit trails and systematic flow of data to monitor data from creation to printing and ensuring (ALCOA) data integrity principles.• Track electronic data bath (Hplc, UV, GC..) to capture any violations or manipulations of data • Write and follow electronic data OOS investigations and provides a correction actions.• Develops standards and operating procedures to reduce the occurrence of Out-of-Specification results in the Analytical QC Lab.• Creating user accesses in electronic data software’s and specifying each user privileges according to job descriptions and authorities • Training of lab analysts using the chromatographic software’s according to the (ALCOA) data integrity principles to insure trustiness of data • Develops and maintains Performance Improvement and quality control program• Develops standards of performance and performance evaluations.• Provides technical oversight of labs, equipment and testing, makes recommended changes and serves as a resource for problem solving and process improvement.• Implement and maintain strong workflow processes and systems for good lab management to include workload, cycle, and productivity assessments, data integrity • Hands-on laboratory work preparing samples and running the HPLC, GC, and Dissolution instrument to execute experiments for collaboration and application development projects. Show less • Professional use of HPLC (Hitachi, Dionex ,Waters, Jasco ,Agilent), Gas chromatography, Atomic Absorption, IR Spectrum, Dissolution, Potentiometer& UV Spectrophotmetry• Writing SOP’s for instruments.• Calibration and maintenance of (HPLC, GC, Dissolution, IR, Atomic Absorption, Hardness, Karl• Fischer, Moisture Analyzer,and Balances)• Run sampling, chemical and physical analysis on raw materials, packing materials, semi-finished and finished products, (Assay, Dissolution, Content Uniformity, Related Substances, Hardness, Friability, Disintegration, Loss on Drying, Water Content)• Carry out documentation tasks including:• Record and evaluate data from test results• Report to manager on work performed and analysis results on regular basis (daily, weekly, monthly).• Implementation of the relevant section of pharmacare’s PQM in the Dept• Receiving, checking, adequate labeling and proper storage of all reagents at pharmacare to insure they are continuously in line with PQM requirements.• Carry out IPQC tests during the manufacturing process and to record, review, evaluate• Preparing working standards against Primary standards, test solutions,• colormetric solutions, volumetric solutions. Show less

  • Quality Controller

    Apr 2017 - Sept 2021

  • Microbiology Supervisor

    Aug 2016 - Sept 2021

  • Quality Control Analyst- chemist

    Apr 2012 - Aug 2016

  • Research Assistant-Biology

    Jun 2011 - Apr 2012
• 

  Birzeit Pharmaceuticals Factory

  Sept 2021 - Oct 2022

  Microbiologist

  Quality controller

• 

  Pharmacare PLC

  Apr 2023 - now

  Head of microbiology lab.