Ewelina Kapałka
TR&D Quality Assurance Senior Specialist at Polpharma Biologics- Claim this Profile
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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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TR&D Quality Assurance Senior Specialist
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May 2023 - Present
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TR&D Quality Assurance Specialist
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May 2021 - May 2023
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TR&D Quality Compliance Junior Specialist
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Aug 2020 - May 2021
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Clinical Research Assistant
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Apr 2020 - Aug 2020
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BLIRT S.A.
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Poland
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Biotechnology Research
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1 - 100 Employee
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Technical Manager
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Apr 2019 - Apr 2020
1. Supervision over the GLP and GMP system in the laboratory (verification of timeliness of IQ/OQ/PQ qualifications and internal and external equipment checks, control and monitoring of laboratory environmental conditions, supervision over the unit's waste policy, supervision over certified reference materials, health and safety) 2. Supervision of the test material (including pre-clinical and clinical biological material): recording, monitoring of storage conditions, distribution of the test material, back-up and archiving, supervision of post-test material handling 3. Checking IQ, PQ, OQ qualification protocols for compliance with GLP and GMP rules, approving documentation, supervising the correctness and completeness of qualification documentation 4. Planning and making purchases to maintain the proper functioning of the laboratory, qualification and verification of subcontractors and suppliers taking into account GLP and GMP requirements 5. Verification of standard operating procedures (SOPs) and instructions Show less
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Senior Specialist
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Jan 2011 - Mar 2019
1. Quality assurance systems GLP/ 17025/9001 creation and development, supervision over creation of standard laboratory procedures, supervision over the implementation corrective and preventive actions after internal/external audits, risk analysis 2. Excellent knowledge of aseptic techniques used in vitro plants cells 3. Plant tissue cultures analysis (explants preparation, micropropagation, callus induction and plant regeneration) 4. Molecular analysis (DNA isolation, Genomic DNA purity and quality measurements UV Vis, PCR reaction, gel electrophoresis of nucleic acids) 5. Work with pathogens II class human safety and plant pathogens, (microbiological cultures, reduction, determination according standards, preparation bacterial elicitors for in vitro cultures) Show less
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Intern
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Jan 2010 - Dec 2010
1. Preparation of buffers and solutions for physicochemical analysis 2. Preparation of media used to in microbiological and in vitro cultures 3. Molecular analysis using PCR techniques, gel staining 4. Microbiological analysis 5. Plant culture in vitro breeding 6. Extraction of plant metabolites using a Soxhlet apparatus and HPLC analysis 1. Preparation of buffers and solutions for physicochemical analysis 2. Preparation of media used to in microbiological and in vitro cultures 3. Molecular analysis using PCR techniques, gel staining 4. Microbiological analysis 5. Plant culture in vitro breeding 6. Extraction of plant metabolites using a Soxhlet apparatus and HPLC analysis
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Education
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Uniwersytet Gdański
Magister (Mgr), biologia/biologia eksperymentalna