Andra-Madalina Bivolaru
Timisoara,Romania
Summary
Experienced Supplier Qualification Manager with a strong track record in managing supplier performance to ensure compliance with quality and regulatory standards. Skilled in conducting comprehensive supplier assessments, leading audits, and implementing effective risk mitigation strategies. Expertise in supplier management, cross-functional collaboration, and leveraging AI and Copilot tools to enhance decision-making and optimize operational processes. Successfully contributed to the development and implementation of a supply chain visibility project, improving transparency and efficiency across the supply chain. Focused on continuous process improvements to ensure regulatory compliance and drive supply chain performance
Overview
5
5
years of professional experience
Work History
Manager Global Quality Supplier Qualification
STADA Group
Timisoara, Romania
05.2022 - Current
- Contributed to the coordination of global GMP-related auditing and qualification processes, fostering continuous improvement of the overall system.
- Assisted in the creation and maintenance of the annual global audit planning list in line with EU-GXP guidelines and local Medicines/Pharmaceutical Acts, ensuring cost-effective audit planning.
- Coordinated global GMP-related audits, including organization, management, execution, and closure, as well as issuance of Supplier Qualifications and QP declarations.
- Managed change control processes in EQMS and supplier releases in SAP, ensuring compliance and efficiency.
- Proficient in project management; successfully led a project focused on supply chain visibility to enhance transparency, optimize processes, and improve overall efficiency.
Pharmacy Resident
Spitalul Clinic Județean de Urgență "Pius Brînzeu"
Timisoara, Romania
01.2022 - Current
- Acquired theoretical knowledge of pharmaceutical raw materials and gained a deep understanding of their roles in formulation, preparation, stability, and drug conditions.
- Enhanced skills in patient counseling by providing clear and personalized information and guidance on medications to ensure safe and effective use.
- Worked as a resident pharmacist, applying knowledge in a practical setting to support patient care and medication management.
Quality Analyst
STADA Group
Timisoara
07.2021 - 05.2022
- Conducted tests to analyze the chemical composition of medications, verifying the concentrations of active and inactive ingredients.
- Analyzed tablets to ensure that the dosage of active ingredients met established specifications.
- Evaluated the physical and chemical properties of medications, including solubility, stability, and shelf-life, performing tests for pH, moisture content, and density.
- Ensured that medications met quality standards and regulatory requirements by testing final products for purity, potency, and uniformity specifications.
- Executed quality control tests on drug samples to identify any deviations from standards and detect potential manufacturing issues.
Expert Reviewer
Help Net
Timisoara, Romania
07.2020 - 07.2021
- Effective in conveying complex information to healthcare professionals and patients, delivering clear, actionable recommendations.
- Possess a deep understanding of pharmacology, drug interactions, and therapeutic guidelines.
- Familiar with regulatory requirements and standards governing medication use and pharmacy practice.
Education
Pharmacy
Victor Babeş University of Medicine and Pharmacy T
Skills
- Business acumen
- Crisis handling
- Attention to Detail
- Data analysis
- Problem-Solving and Decision-Making
- Team orientation
Languages
English
Spanish
Custom
- Photography
- Fitness and Wellness:
- Volunteering
- Reading
Timeline
Manager Global Quality Supplier Qualification
STADA Group
05.2022 - Current
Pharmacy Resident
Spitalul Clinic Județean de Urgență "Pius Brînzeu"
01.2022 - Current
Quality Analyst
STADA Group
07.2021 - 05.2022
Expert Reviewer
Help Net
07.2020 - 07.2021
Pharmacy
Victor Babeş University of Medicine and Pharmacy T
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