Marcin Malkuszewski
Key Expert at Polpharma Biologics- Claim this Profile
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English Professional working proficiency
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Polish Native or bilingual proficiency
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Russian Elementary proficiency
Topline Score
Bio
Experience
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Polpharma Biologics
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Poland
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Biotechnology Research
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700 & Above Employee
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Key Expert
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Apr 2021 - Present
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Expert
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Apr 2019 - Apr 2021
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Senior Drug Product Specialist
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Dec 2017 - Apr 2021
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Pfizer
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Production Supervisor
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Jun 2013 - Jun 2017
• Process Efficiency and Cost Saving Improvements (also via Change Management process) • Training Supervision duties (as per Training Supervisor role) • Customer Services duties (ordering, complaints) • Ascura online software development • Team Management (approximately 30 indirect and 6 direct) • Conducting performance reviews • Auditing duties (self-inspections, patrol audits) • Event Management (Investigations, CAPAs) • Creating and Reviewing QMS documentation • Taking care of equipment directly or with a help of servicing team via Unplanned Maintenance • Taking part in Assessment Centre for Interviews purposes • Scheduling work for Production teams • Sustaining compounding/dispatching/inspecting duties Show less
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Hospira
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Training Supervisor
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Jan 2011 - Jun 2013
• Implementing and Administrating ISOtrain and iKAT training software• Testing and using ASCURA web ordering and manufacturing software• Designing and implementing training programs from scratch for new compounding unit• Taking part in Assessment Centre for Interviews purposes• Taking part in validation of new compounding unit• Compounding aseptic products in isolators• Experience in going through MHRA, EHS and NHS inspections• Fire Warden and First Aider • Trained in Environmental Monitoring process (particle counting, active air sampling, agar plates reading etc.) Show less
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Technical Trainer
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Jan 2010 - Jan 2011
• highly experienced in compounding sterile products in the sterile environment - clean room; VLF and HLF cabinets (Total Parenteral Nutrition, chemotherapy drugs, pain killers, antibiotics, monoclonal antibodies)• disinfection of critical areas• knowledge of cGMP• preparing documentation SOPs • maintaining appropriate environmental monitoring records• 6 accreditations (set up checker – Chemo and TPN unit, volume checker, paperwork checker, Baxa EM2400 operator, HEPA filter checker)• 2 months rotation in the Quality Control Department • Administrator of the ISOtrain software, user of the ASCURA Web Ordering Hospira Software, user of the Error Reporting Hospira Software• Over a year in Training Department, delivering training programs Show less
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Senior Technician
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Sep 2008 - Jan 2010
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Technician
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Jul 2007 - Sep 2008
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Technical Assistant
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Mar 2006 - Jul 2007
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Education
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University of Gdansk
Master’s Degree, Environmental Science