Svetlana Busija
Summary
A quality-focused Scientist with strong analytical skills gained within QC and QA departments in the pharmaceutical and FMCG industries. Throughout my 12 years of experience in the pharmaceutical industry, I have performed various laboratory tests and procedures with experience, high attention to detail and optimum quality. I have achieved the Authorised Person position as my latest addition to my achievement, knowledge, and skills. My dedication drives me to excel both independently and collaboratively, approaching new challenges with enthusiasm, optimism and vigour.
Overview
11
11
years of professional experience
Work History
Quality Associate-Incoming Receipt and Release and Authorized Person
PCI Pharma Services (Clinical Medical Trial)
07.2022 - 06.2024
- Review and disposition (release or reject) batch records for bulk manufacturing, sterile and finished product for supply as per regulatory requirements
- Perform batch release for R&D, Phases 1, 2 and 3 clinical trial products
- Develop a strong communication between Quality, Production and Project Managers to resolve any issues found during manufacturing
- Review and approval of master batch record template, finished product specification
- Preparation of CoA’s and CoC’s for released batch record and SOP’s
- The receipt, testing, review, inspection, quarantine, and disposition of incoming material for use in production
- Review and approved preparation, issuance, and approval of labels
- Assist in Internal and External audits
- Support the close out of deviations, CAPA, change control, non-conforming materials/products
- Assist production with approval to proceed with production activity
- Partner with production to provide assistance with monitor aseptic operation and compliance status
- Perform facility inspection(filing and packaging room) perform Quality Assurance activities related to Process Improvement
- Perform batch auditing in multiple areas of production(All areas of filling, inspection and packaging)
- Review executed batch records, and associated documentation for compliance with cGMPs and consistency with other PCI policies and procedures
- GxP compliance prior to the release of critical drug product to the patient
- Interpret and implement quality assurance standards
- Quality oversight and preparation of some quality control documents
- Assist in the maintenance of the cGMP facility licence
- Support production with quality requirements and issue.
- Experience with reviewing equipment qualifications protocols (IQ,OQ and PQ)
Quality Control Associate Incoming Receipts and Release
PCI Pharma Services (Clinical Medical Trial)
03.2022 - 07.2022
- The receipt, testing, review, inspection, quarantine, and disposition (release or rejection) of incoming materials for use in production, in accordance with company procedures.
QC Analyst
ASPEN PHARMA
10.2018 - 01.2022
- Perform finishing product testing, stability product and process validation testing on tablets, liquids, capsules, creams, sterile products, and injectable products
- Running of different analytical instruments to meet the target of releasing the product on the market.
Laboratory technician (QC and QA)
ROHA AUSTRALIA
11.2017 - 10.2018
- Perform sampling on all raw materials
- Quality control testing natural and synthetics colours, dyes, pigments, and lakes for food industries
- Quality Assurance documentation preparation (CoA, SDS, Specs)
- Perform colour matching and new product development/formulation/validation
- Testing pigments, dyes and colours for plastics, paint, inks, coatings, art, and crafts
- Operating lab hunter instrument to perform colour matching
- Operating Injection moulding machine 'Boy'
- Review and evaluate QC data for release and approval of batch records
- Coordinate lot release schedule with operations and warehouse managements to ensure efficient and on time release of product batches.
Laboratory technician
MONASH UNIVERSITY
06.2017 - 11.2017
- Autoclaving strilization(glassware, instrument, buffers, solutions)
- Perform biological procedures
- Prepare tissue and cell culture
- Perform microscopic examination
- Process and interpret data.
Quality Control Chemistry Analyst for Sterile product and raw material
HOSPIRA AUSTRALIA, A PFIZER PHARMACEUTICAL COMPANY
01.2013 - 11.2016
- Conducting day-to-day analytical testing on raw material, finishing products glass(vials) rubber closures and component testing (packing, cartons, and leaflets)
- Preparing chemical solutions, buffers, reagents for testing as per products method
- Checking the preparation and results of another Analyst's
- Validation of new instruments and update to methods
- Recording and checking and verified the result of the analysis in the laboratory information management system (LIMS)
- Operating, calibrating, and maintaining, chemistry analysis equipment: HPLC, UV/VIS, FTIR, ICP, AAS, TOC, pH Meters, Melting Point, Density, Calorimeter, Refractometer and Tintometer, Water Content Determination: Coulometric 686 & 737 KF-Standalone system and 756 KF-Tiamo systems Potentiometric Determination, Auto titrators, and Autoclave
- I also used many software applications including Empower, Tiamo, UV vary and LIMS system, JDE, and SAP
- Preparing and managing batch records
- Participating in Continuous improvement strategies (5S technique)
- Ordering of standards, reagents, instruments parts and consumables.
Education
Skills
- Authorised Person
- CGMP for Aseptic Manufacturing -Sterile Injectable
- Regulatory compliance TGA and FDA
- Terminal Streilization Process
- Filtration
- Clinical trials- Gel, tablet, and capsule manufacturing
- Change control
- Root Causes Analysis
- LIMS and JDE System
- HACCP
- Problem solving
- Packaging and labelling
- Incoming material release
- Knowledge of wet and analytical chemistry techniques
- Soil and water testing
- Perform food testing
- Perform biological procedures
- Prepare tissue and cell culture
- Performed microscopic examination
Timeline
Quality Associate-Incoming Receipt and Release and Authorized Person
PCI Pharma Services (Clinical Medical Trial)
07.2022 - 06.2024
Quality Control Associate Incoming Receipts and Release
PCI Pharma Services (Clinical Medical Trial)
03.2022 - 07.2022
QC Analyst
ASPEN PHARMA
10.2018 - 01.2022
Laboratory technician (QC and QA)
ROHA AUSTRALIA
11.2017 - 10.2018
Laboratory technician
MONASH UNIVERSITY
06.2017 - 11.2017
Quality Control Chemistry Analyst for Sterile product and raw material
HOSPIRA AUSTRALIA, A PFIZER PHARMACEUTICAL COMPANY
01.2013 - 11.2016
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