Experience

Polpharma Biologics

• Poland
• Biotechnology Research
• 700 & Above Employee

• Quality Operations Expert

  • Jan 2021 - Present

• Quality Operations Senior Specialist

  • Jul 2019 - Jan 2021



GE HealthCare

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Site Microbiologist/ Senior Quality Control Microbiologist

  • Nov 2015 - Mar 2019

  • Incident Reports investigations applying 5Whys and Fishbone. Using TrackWise Quality Management System for initiation of Change Controls (CC), authorization of deviations, implementation and approval of corrective and preventative actions (CAPA), writing impact assessments and evaluations to support the changes to be introduced on site • Assessment of possible failures in processes, products, equipment and the consequences using FMEA tool • Continuous improvement to documents, SOPs and forms by periodic review, update or withdrawal using MyDoc system and Veeva Vault Docs • Final approval of testing results of product batches, manufacturing records, released raw materials, forms and logbooks assuring the accuracy and consistency of data (data integrity) • Autoclaves and Oven Maintenance and Requalification Reports review and approval • Processing of Biological Indicators (BI) and authorization of autoclaves to certify the sterilization • Trending of the results using spreadsheets and graphs. Monitoring regulatory and industry trends • Validation of new processes, equipment and/or systems using URS, IQ, OQ, PQ • Internal and external audits (auditing main production areas and company’s suppliers) • Providing microbiological advice to other site functions at departmental meetings, Quality Council meetings, Sterilization meetings, Change Control meetings and any urgent OOS meetings • Actively participating in Lean Six Sigma certification of QC Microbiology laboratory • Performing the other duties of QC Microbiologist: water and products bioburden testing, solid and liquid media validation, standardized bacteria qualifications, environmental monitoring, microbial identification, endotoxins testing and sterility testing of final products Show less



Moorfields Pharmaceuticals

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• QC Microbiologist

  • Sep 2012 - Jul 2015

  • Performing Environmental Monitoring of Pharmaceutical Clean Rooms, documenting the results and reporting Out of Specification/Out of Trend values in accordance with laid down Standard Operating Procedures and regulatory requirements. • Monitoring the Water Systems (Water for Injection, Purified Water, and Raw Water) for contamination and bioburden levels. • Monitoring products for microbial contamination using the membrane filtration method (bioburden testing of pre filtration, pre filling and in process samples) • Assessment of microbial contamination of personnel (gowning, aseptic transfer, and aseptic techniques). • Enumerating and identifying environmental isolates to species level using API ID System. • Undertaking endotoxins testing using Turbidimetric method and Gel Clot method. • Processing Biological Indicators (SterilAmp, MesaStrip) and Hydrogen Peroxide Vapor Indicators (Bioquell HPV-BI) after validation or sterilization processes. • Performing validation studies with regards to development, change of procedures including fertility testing and growth promotion studies. • Performing risk assessment for the rebalancing of HVAC system. Witnessing smoke test studies to establish new Environmental Monitoring locations. • Writing reports on conclusion of testing, raising and investigating non-conformances if results are out of specification or out of trend. • Performing root cause analysis investigations. Assigning, implementing and checking for effectiveness of CAPAs (Corrective Action and Preventative Action). Show less



Moorfields Pharmaceuticals

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Pharmaceutical Operator

  • 2010 - 2012

  • Working in a controlled sterile environment, carrying out aseptic procedures using sophisticated equipment and medical devices to manufacture and package medicinal products (sterile bulk solutions, eye drop bottles, and syringes). • Generating labels and cartons for finished products. • Ensuring that work areas maintain high standards of housekeeping (following 5S methodology). • Maintaining and monitoring Grade A, B and C environment. • Improving the processes and procedures used in the production department. Writing and updating master batch documentation, forms and Standard Operating Procedures. • Leading the close out and further necessary investigation of GMP non-compliances. Implementing and closing out changes through the Change Control System. • Creating User Requirement Specification for new equipment. • Training new staff. Show less



Royal Free London NHS Foundation Trust

• Hospitals and Health Care
• 700 & Above Employee

• Pharmaceutical Operator

  • 2008 - 2010

  • Preparing prescribed “specials” for the hospital patients and outpatients (creams, capsules, syringes, infusion bags, total parenteral nutritional bags and cytotoxic infusions). • Manufacturing of bulk products: oral and topical solutions, mixtures, infusers, creams. • Manufacturing of Clinical Trials products: placebo and active ingredients. • Visually inspecting, labeling and packing final products. • Preparing prescribed “specials” for the hospital patients and outpatients (creams, capsules, syringes, infusion bags, total parenteral nutritional bags and cytotoxic infusions). • Manufacturing of bulk products: oral and topical solutions, mixtures, infusers, creams. • Manufacturing of Clinical Trials products: placebo and active ingredients. • Visually inspecting, labeling and packing final products.



Warman Freed Pharmacy

• London, United Kingdom

• Pharmacy Assistant

  • 2007 - 2008

  • Medicines and medicinal products order maintenance and transmission. • Dealing with medical representatives, managing doctors and customers’ queries, preparing medicines’ trays for nursing homes. • Booking in prescriptions, handing out dispensed medications, selling over the counter medicines, providing information and advice to patients on health issues. • Medicines and medicinal products order maintenance and transmission. • Dealing with medical representatives, managing doctors and customers’ queries, preparing medicines’ trays for nursing homes. • Booking in prescriptions, handing out dispensed medications, selling over the counter medicines, providing information and advice to patients on health issues.



Frank Wreford Chemist

• London, United Kingdom

• Pharmacy Assistant

  • 2006 - 2007

  • Selling over the counter non – prescription medicines, taking in prescriptions, handing out completed dispensed items, advising customers on health matters – symptoms and products. • Selling over the counter non – prescription medicines, taking in prescriptions, handing out completed dispensed items, advising customers on health matters – symptoms and products.



Regional Specialist Hospital

• Suwalki, Podlaskie District, Poland

• Biomedical Scientist

  • 2005 - 2005

  • Performing examinations and diagnosis using a wide range of complex modern techniques and laboratory equipment in all laboratory disciplines (medical microbiology, clinical biochemistry, haematology and immunology). • Performing examinations and diagnosis using a wide range of complex modern techniques and laboratory equipment in all laboratory disciplines (medical microbiology, clinical biochemistry, haematology and immunology).