Aleksandra Marut
QA Specialist at DDD Ltd.- Claim this Profile
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Bio
Experience
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DDD Ltd.
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1 - 100 Employee
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QA Specialist
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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.
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ITH Pharma
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Senior Quality Technician
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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
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Quality Control Technician
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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
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Senior Quality Control Assistant
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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
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Compounding Operator
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Oct 2012 - Mar 2013
- Operating Baxa EM2400 compounder- Supervising in cleanroom and preparation area- Set up checking/ volume accuracy checks
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Aseptic Compounder
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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
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Intern in Quality Department
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Oct 2009 - Apr 2010
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Education
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Jagiellonian University
CRA workshop -
Jagiellonian University
Project Management workshop -
Jagiellonian University
Postgraduate diploma, Clinical Trials – Methodology, Organisation and Management of Clinical Studies -
Jagiellonian University
ICH GCP course -
Wroclaw University of Science and Technology
Master's degree, Materials Engineering