Daniela Hristova

Chemical Engineer and Quality Management professional with 20+ years of experience in the pharmaceutical industry, covering Quality Control, Quality Assurance, Validation and Regulatory Affairs in GMP-regulated environments. Experienced in pharmaceutical manufacturing, laboratory management, quality systems, process/cleaning/method validation, stability studies, deviations, CAPA, change control, data integrity and CTD Module 3. Currently working as QC Manager in the Netherlands.

QC Manager - Floris Veterinaire Producten BV - The Netherlands

(2021-10)

• Perform GMP-compliant QC testing of veterinary pharmaceutical products against approved specifications and procedures.
• Review analytical results, laboratory documentation and Certificates of Analysis for accuracy and GMP compliance.
• Coordinate and supervise daily QC laboratory activities, planning and workflow.
• Support Process Validation, Cleaning Validation, Method Validation, method verification and analytical method transfer.
• Conduct Stability Studies and evaluate analytical data against approved protocols.
• Participate in deviation investigations, root cause analysis, CAPA and Change Control activities.
• Support Data Integrity implementation in accordance with ALCOA+ principles and review controlled quality records.
• Train, mentor and supervise laboratory personnel; collaborate with QA, Production and Regulatory Affairs.

Regulatory Affairs Specialist - Adipharm Sofia - Bulgaria

(2020-02 - 2020-08)

• Prepared and maintained regulatory documentation for medicinal products.
• Prepared and reviewed CTD Module 3 (Quality Documentation) according to EU regulatory requirements.
• Prepared regulatory submissions, variations and renewals and coordinated with Regulatory Authorities and business partners.
• Reviewed pharmaceutical quality documentation, analytical reports and specifications in collaboration with QA, QC and Manufacturing.

Senior Chemist - Actavis Dupnitsa - Bulgaria

(2001 - 2019)

• Performed QC testing of pharmaceutical products, including HPLC and UV-Visible Spectroscopy.
• Worked on Method Validation, Stability Studies, analytical documentation review and GMP documentation.
• Investigated analytical results and trained laboratory personnel.

Laboratory Operator - Balkanpharma Dupnitsa - Bulgaria

(1989 - 2001)

• Performed in-process QC and analytical testing of pharmaceutical products.
• Handled sampling/testing of raw materials and finished products and maintained laboratory documentation in compliance with GMP.

Master’s Degree - Quality Management - University of Chemical Technology and Metallurgy (UCTM), Sofia, Bulgaria

Bachelor’s Degree - Chemical Engineering - University of Chemical Technology and Metallurgy (UCTM), Sofia, Bulgaria