Aleksandra Marut

QA Specialist at DDD Ltd.
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Contact Information
us****@****om
(386) 825-5501
Location
Hemel Hempstead, England, United Kingdom, UK

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Experience

    • 1 - 100 Employee
    • QA Specialist
      • May 2018 - Feb 2020

      - Batch review, GMP walkarounds and co-ordination of documentation to support batch release. - Process quality reports concerning Deviations/CAPAs/Audit Findings/Change controls. - Implement and maintain processes/systems to ensure that the site adheres to GMP and maintain site compliance. - Support and train all departments on QA objectives and standards to ensure awareness and compliance with the QMS, GMP/GDP and customer requirements. - Batch review, GMP walkarounds and co-ordination of documentation to support batch release. - Process quality reports concerning Deviations/CAPAs/Audit Findings/Change controls. - Implement and maintain processes/systems to ensure that the site adheres to GMP and maintain site compliance. - Support and train all departments on QA objectives and standards to ensure awareness and compliance with the QMS, GMP/GDP and customer requirements.

    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Senior Quality Technician
      • Jun 2017 - May 2018

      - Ensuring that the quality standards and systems are implemented and maintained in compliance with GMP- Generate, review and update of documented procedures and controlled documentation- Participation in internal audits- Investigate customer complaints and supplier non-conformance issues- Implement, monitor and maintain the Non Conformity Report / Corrective Action Preventive Action processes - Conducting validation activities- Train other personnel in all aspects of Quality Assurance Systems and Procedures- Equipment maintenance Show less

    • Quality Control Technician
      • Apr 2015 - Jun 2017

      - Analysis of samples for intermediate/finished products with ICAP- Gram stain testing- Reporting defective products- Reviewing SOP’s- Report and investigate out of spec results

    • Senior Quality Control Assistant
      • Mar 2013 - Apr 2015

      - Environmental and personnel microbiological monitoring - Preparation of standards and samples for chemical analysis- Operation of analytical instruments (ICAP, refractometer)- Releasing raw materials for production

    • Compounding Operator
      • Oct 2012 - Mar 2013

      - Operating Baxa EM2400 compounder- Supervising in cleanroom and preparation area- Set up checking/ volume accuracy checks

    • Aseptic Compounder
      • Feb 2011 - Oct 2012

      - Aseptic compounding of Cytotoxics, Monoclonal Antibodies, CIVAS and PN products in the clean room- Environmental/ Personal monitoring- Assembly and in-process checking- Ensuring deadlines are met for same day and overnight work- Stock maintenance

    • Intern in Quality Department
      • Oct 2009 - Apr 2010

Education

  • Jagiellonian University
    CRA workshop
    2015 - 2015
  • Jagiellonian University
    Project Management workshop
    2015 - 2015
  • Jagiellonian University
    Postgraduate diploma, Clinical Trials – Methodology, Organisation and Management of Clinical Studies
    2014 - 2015
  • Jagiellonian University
    ICH GCP course
    2014 - 2015
  • Wroclaw University of Science and Technology
    Master's degree, Materials Engineering
    2002 - 2008

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