Team Leader Quality Control
Resume:
Tetiana
Prokopovych
*** ********* ***, ****, **. 27502
*******.***************@*****.***
LinkedIn Profile
https://www.linkedin.com/in/tetiana-
prokopovych-8376872a0/
Summary
Highly motivated and detail-oriented QC team leader with over 10 years of experience in the pharmaceutical industry. Demonstrated success in leading and managing QC finished product teams, performing routine tests, transferring analytical methods, and conducting stability studies for various product types, including pills and capsules products. Possesses a strong command of Quality Control processes and systems, with a deep understanding of cGMP, GLP, and ICH guidelines and regulations. Additionally, adept at supervising and performing the preparation, review, and verification of QMS components, such as Deviation, Investigation, Change Control, and CAPA.
Skills
• Skilled in handling and analyzing pills and capsules
• Strong record of independent work, consistently delivering results through efficient multitasking
• Proven experience preparing and reviewing technical documents like investigations, reports, and protocols
• Skilled in managing conflicting deadlines and adapting to changes in priorities
• Expertise in preparing and reviewing Deviation investigations, Out-of-Specification
(OOS) investigations, Corrective and Preventive Actions (CAPAs), CoAs, laboratory events, stability protocols, analytical protocols, and reports
• Excellent data review skills, understanding the critical significance of data integrity
• Proficient in HPLC, UPLC, LC-MS, UV/VIS, KF, Viscosity, APSD (NGI), FPM, Spray pattern, Adhesive forces, and Cold flow tests
• In-depth knowledge of Empower 3, LIMS (Labware), TrackWise, MS Word, MS Excel, MS PowerPoint, MS Outlook, Adobe Acrobat, as well as familiarity with USP, European Pharmacopeia, and British Pharmacopeia
2
Professional Experience
Acino Pharma AG, Ukraine
Head of QC laboratory, 2021 – 2023
● Planned, assigned, and directed all laboratory work, including finished product release, in-process release, raw material release, and stability testing release.
● Designed and modified workflows to ensure the highest quality data and optimal resource utilization.
● Supervised the preparation, review, and verification of TrackWise system entries for deviations, investigations, change controls, risk management, and CAPAs.
● Managed the calibration of analytical instruments and equipment.
● Designed, developed, implemented, and maintained the training program for laboratory personnel.
● Ensured an effective document management system in the laboratory. Acino Pharma AG, Ukraine
Team leader of QC, 2018 – 2021
● Planed, organized, delegated, arranged resources
● Ensured the completion of the team’s responsibilities
● Transferred test methods for finish products, API, and excipients.
● Provided routine analysis of products (pills and capsules) internal and external clients using established laboratory test procedures utilizing high productivity and time management
● Managed stability studies
● Proactive preventative maintenance and troubleshooting of laboratory equipment Acino Pharma AG, Ukraine
Senior chemist, 2017 – 2018
● Conduct comprehensive analysis of pharmaceutical products using a variety of analytical techniques
● Oversee stability studies, evaluating the long-term effects of environmental factors on drug formulations
● Executed routine analysis of raw materials, intermediates, and finished products, ensuring quality and adherence to specifications
● Assisted in the development and validation of analytical methods for drug substances and drug products
● Contributed to the preparation of regulatory documents and responded to inquiries from regulatory agencies
● Conducted investigations into out-of-specification results and implemented corrective actions
Acino Pharma AG, Ukraine
Chemist analyst, 2013 – 2017
● Conducted stability studies of products
● Transferred and implemented new methods into QC laboratory
● Authored SOPs, transfer protocols and reports
● Tested API, raw material, excipients, packaging materials 3
● Communicated with scientists and engineers to developed nonstandard tests and scientifically interpreted results
Education
M.S., Ecology / National Technical University of Ukraine "Igor Sikorsky Kyiv Polytechnic Institute" - 2006
B.S., Ecology / National Technical University of Ukraine "Igor Sikorsky Kyiv Polytechnic Institute" - 2001
Certifications
Standards, Technology, Development. Mistakes of analytical experiment - 2017. Waters Educational Services. Empower Basic Training - 2019. Waters Educational Services. Empower Advanced Training - 2019. Inpharmatis. Data integrity - 2021.
Quality laboratory Manage of QC laboratory - 2021.
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