Fatemeh Mehrzad Tabrizi
Hellerup
Summary
Detail-oriented and experienced pharmacist with a robust background in quality assurance (QA) within the commercial department, coupled with roles as a Qualified Person (QP) delegate and Contract Manufacturing Organization (CMO) responsible. Proficient in managing workflows, delegating tasks, and reporting progress effectively. Demonstrates exceptional skills in ensuring compliance with both US and EU Good Manufacturing Practices (GMP) regulations across small molecule and biologic products, overseeing quality systems, and managing external manufacturing processes to maintain product integrity and safety. Strong ability to streamline processes, manage projects, and support GMP critical aspects. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
10
10
years of professional experience
Work History
QA Specialist - Corporate Product Quality Department for Biologics
H. Lundbeck A/S
01.2024 - Current
- Acted as QP delegate, maintaining stringent quality oversight, including handling release, change requests, and deviations.
- Ensured compliance with both US and EU GMP regulatory standards and internal quality policies when conducting QA and QP delegate activities.
- Performed comprehensive evaluations of vendors (CMO's producing BDS, DP and FP) and reviewed Product Quality Reviews (PQR), upholding the highest quality standards and regulatory requirements.
- Implemented robust process enhancements, rigorously upholding US and EU regulations, encompassing vendor evaluations, PQR creation, and release procedures for BDS, DP, and FP. Streamlined operations, eliminating non-value-added activities, resulting in heightened efficiency and cost-effectiveness.
- Empowered team for GMP compliance, fostering collaboration, expert QA guidance, and continuous improvement.
- Provided support to the QC department, assisting with changes in vendor evaluation procedures for all Contract Testing Laboratories (CTLs) and aligning procedures with headquarters when taking over QC activities from the US department.
- Implemented comprehensive process improvements, streamlining operations and eliminating non-value-added activities, resulting in heightened efficiency and cost-effectiveness.
Senior System Responsible, CPQ Small Molecules
H. Lundbeck A/S
05.2022 - 12.2023
- Acted as the main quality contact for CMOs, facilitating regulatory compliance and operational efficiency.
- Directed comprehensive QA oversight for CMOs, maintaining stringent compliance with GMP regulations.
- Diligently reviewed and authorized CMO master batch records, upholding high-quality standards.
- Evaluated and approved master batch records from CMOs, ensuring conformity with GMP guidelines.
- Verified and endorsed manufacturing records and QC documentation, maintaining regulatory compliance.
- Established and updated batch record and authorization standards, maintaining rigorous GMP adherence.
- Supported business partners and new projects
- Optimized processes to enhance efficiency and compliance, reducing operational redundancies.
- Conducted rigorous vendor evaluations through detailed PQR reviews, ensuring contract compliance, GMP adherence, and delivery of high-quality products from CMOs.
- Participated in auditing CMOs and took part in regulatory inspections of our department as the CMO responsible, ensuring sustained audit readiness and regulatory compliance.
- Advanced previous QA academic duties, ensuring sustained quality and compliance excellence.
- Acted as the QP delegate, ensuring batch release processes met all regulatory requirements
- Conducted comprehensive training sessions on quality and compliance, fostering a knowledgeable workforce.
QA Academic
H. Lundbeck A/S
03.2014 - 04.2022
- Acted as QP delegate
- Led CMO quality oversight since August 2020, ensuring adherence to quality agreements.
- Executed batch review and release processes for finished goods, ensuring GMP compliance.
- Created and approved deviation, change requests, and Certificates of Analysis (CoAs)
- Authorized release of CMO-produced finished goods and bulk products.
- Addressed and resolved CMO deviations and change requests in accordance with GMP regulations.
- Conducted comprehensive review, update, and approval of QA documentation (standard operation procedures (SOPs), batch records and work instructions)
- Administered qualification, requalification, and test approval procedures, ensuring stringent GMP compliance for equipment in production areas.
- Responsible for ampoule and drops production line (finished goods)
- Provided GMP-focused support to Engineering & Facility Management, ensuring regulatory adherence in facilities and utilities.
Education
Master of Science - in Pharmacy
Faculty of Pharmaceutical Sciences
Copenhagen12.2010
Skills
- Project Management & Training
- Task Delegation & Workflow Management
- Process Optimization
- Compliance Documentation
- Regulatory Compliance & Risk Management
- Quality Management Systems (QMS)
- Requirements Analysis
- Analytical Problem-solving
- Collaboration and Communication
- Attention to Detail & Time Management
Languages
Danish, Persian
Native language
English
Proficient
C2
Timeline
QA Specialist - Corporate Product Quality Department for Biologics
H. Lundbeck A/S
01.2024 - Current
Senior System Responsible, CPQ Small Molecules
H. Lundbeck A/S
05.2022 - 12.2023
QA Academic
H. Lundbeck A/S
03.2014 - 04.2022
Master of Science - in Pharmacy
Faculty of Pharmaceutical Sciences
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