Aleksandar Damjanovic
Qualified Person / QA Specialist
Breda
Summary
Proven Qualified Person/QA Specialist with 5 years of experience in the pharmaceutical and medical devices industry, adept in regulatory frameworks and fostering team collaboration, enhancing product quality and process efficiency. Expertise in shortage management and cross-functional collaboration with aim to ensure continuous quality product availability. Achieved complex issue solving and integration of automation, improving project timelines and compliance.
Seeking to leverage extensive knowledge in quality assurance and regulatory framework to contribute to the effective management of medicines and medical devices shortages, ensuring consistent product availability and patient safety.
Key strengths include regulatory knowledge, risk assessment, process optimization, and strategic problem-solving in high-pressure and multi-cultural environment.
Overview
5
5
years of professional experience
Work History
Qualified Person/QA Specialist
Amgen
Breda, Netherlands
01.2022 - Current
- Ensured continuous supply of products that meet necessary quality standards by certification and batch release of commercial and clinical products in accordance to Annex 16, Volume 4 and Volume 10 EudraLex.
- Provided quality support to Supply Chain, Regulatory Affairs and Production Planning teams in relation to EMA regulatory requirements as well as GMP and GDP guidelines throughout product’s life cycle (product launches, maintenance and retirement) by means of creating and reviewing implementation strategies, and complex issue handling meant to prevent drug product shortages.
- Served as subject matter expert within Senior Leadership team in relation to Management Review, providing guidance and fostering a collaborative work environment focused on matters related to Regulatory Trends, Business Environment, Business Objectives and Innovation Initiatives.
- Supported in various QA related process e.g. recalls, audits & inspections, EU FMD compliance
Senior QA Associate
Amgen
01.2020 - 12.2021
- Led cross-functional teams for efficient collaboration, resulting in timely project completion.
- Developed robust automation frameworks that significantly reduced manual testing efforts and increased efficiency.
- Fostered strong relationships with other departments such as development, support, and product management to promote seamless communication throughout entire product lifecycle.
- Ensured compliance with SOPs and regulatory requirements by providing daily guidance and support to Production and Engineering staff, reviewing and approving batch record documentation, deviation records and compliance checks
- Supported in maintaining continuous supply of quality medicines by analyzing and reporting metrics related to Disposition Lead Time
Education
Master of Science - International Pharmaceutical Business Management
Griffith College
Cork 04.2001 -
Master of Science - Pharmacy
Faculty of Pharmacy University in Belgrade
Belgrade, Serbia 04.2001 -
Skills
Regulatory framework
Applied knowledge
Team collaboration
Communication
Cross-cultural sensitivity
Continuous learning and self-development
Shortage management & availability
Languages
Croatian
Native language
English
Proficient
C2
Dutch
Intermediate
B1
German
Elementary
A2
Timeline
Qualified Person/QA Specialist
Amgen
01.2022 - Current
Senior QA Associate
Amgen
01.2020 - 12.2021
Master of Science - International Pharmaceutical Business Management
Griffith College
04.2001 -
Master of Science - Pharmacy
Faculty of Pharmacy University in Belgrade
04.2001 -
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