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Munir Malek

Munir Malek

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location of Munir MalekGreater Uppsala Metropolitan Area

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  • Timeline

  • About me

    Assessor at Medical Products Agency Läkemedelsverket

  • Education

    • AstraZeneca

      2007 - 2007
      Master's Degree Degree Project, Toxicology D 30-point project (Master Thesis)

      The aim of the project was to establish a method for the detection of protein complexes extracted from tissues or cells under native conditions.During this project I succeeded to set up the BN PAGE ”Blue Native Poly Acrylamid Gel Electrophoresis” method and apply the method on rat heart proteins.

    • Gymnasium komvux Partille, Gothenburg, Sweden

      2002 - 2002
      High School

    • Uppsala University

      2003 - 2007
      Degree of Master of Pharmaceutical Science

    • Uppsala University

      2003 - 2008
      Master's Degree Degree of Master of Science in Pharmacy 300 Credits

      Uppsala University, Pharmacy programme 300 credits, Uppsala, Sweden.

    • University of Bath

      2009 -

      Screening UBELT- Professional English Language Test of Bath University in UK

  • Experience

    • Apoteket - Hospital pharmacist

      Sept 2007 - Dec 2008

      Preparation of Cytotoxic drugs (Drug used in chemotherapy against cancer), Total Parenteral Nutrition (TPN) and preparation of aseptic drugs. I also prepared drug that used in clinical trials at hospital’s pharmacy in Karolinska Hospital, Stockholm, Dispensing prescription drugs to patients and give advice, information and recommendations on drugs and over-the-counter medicines.

      • Hospital Pharmacist

        May 2008 - Dec 2008

      • Pharmacist

        Sept 2007 - May 2008

    • Fresenius Kabi

      Sept 2009 - Apr 2011
      Quality Controller

      - I released drug batches, assessed batch related and non batch related deviations.- I reviewed and approved instructions, documents and specifications.

    • Oriola-KD Corporation

      May 2011 - May 2013
      Qualified Person (QP) / Responsible Person

      Responsible Person (RP) and Qualified Person (QP)- Responsible for handling of deviations- Audits and inspections- Approval of SOPs, validation documentation, etc.- Communication with international drug companies and Swedish medical products agency (MPA)- Trained staff in GDP

    • Cura Apoteket

      May 2013 - Sept 2013
      Pharmacist

      * Dispense prescription drugs to patients * Information and recommendations on over-the-counter medicines

    • Galderma

      Jan 2014 - Jun 2014
      Quality Coordinator

      * Within Quality Assurance (QA) for Medical Devices* Handling and coordinating Post-Market Complaints * Quality Agreements & Risk Management * Trained staff in Risk Management for Medical Devices with focus on ISO 14971 and Annex ZA.

    • Novavax

      Jan 2015 - May 2018
      QA Specialist/ QP

    • Galderma

      May 2018 - Nov 2018
      Quality Assurance Supplier Control Manager

      Performed supplier audits to ensure compliance with CGMP regulations and ISO standards.

    • Medical Products Agency Läkemedelsverket

      Dec 2018 - Nov 2020
      Assessor

  • Licenses & Certifications

    • Registered Pharmacist

      Royal Pharmaceutical Society
      May 2009

    • Legitimerad apotekare - Registered Pharmacist

      The National Board of Health and Welfare (Socialstyrelsen)
      Mar 2008