Ms Office
Simin Madani Kashani
Quality Management
Berlin
Summary
Dynamic Quality Leader with extensive experience at Pharmaceuticals, excelling in project management, CSV and risk management. Proven track record in enhancing compliance and efficiency through effective vendor qualification and cross-functional collaboration based on EU GMP, GAMP5, FDA 21 CFR Part 11 and ISO. Adept at implementing quality assurance processes that increase business success and drive continuous improvement.
Overview
11
11
years of professional experience
2
2
Languages
Work History
CSV Project Leader
Cobel Darou Group
01.2024 - 12.2024
- Collaborated with team members to develop, identify and accomplish assigned goals and objectives.
- Aligned with staff members to develop, identify and achieve assigned goals and initiatives.
- Improved process efficiency through regular evaluation and revision of existing workflows and methodologies.
- Defined responsibilities, duties and roles of team member (RACI chart).
- Reduced project risks through comprehensive risk assessments and proactive mitigation strategies for each module.
- Consistently met deadlines by diligently tracking progress and implementing effective time management strategies.
- Contributed in preparation and defining user requirement specifications
- Led end-to-end validation of 7 quality modules of ERP system under development, ensuring compliance with GAMP5, FDA 21 CFR Part 11and internal GxP standards
- Initiated and generated validation documents and test reports.
- Contributed and conducted test cases to challenge the process against defined URS.
Quality Leader – CMO Oversight & Compliance
Daryan Salamat Pharma Group
07.2023 - 12.2024
- Maintained a comprehensive quality management system, ensuring adherence to regulatory guidelines and best practices.
- Implemented vendor qualification and regulatory compliance programs across CMOs.
- Developed project planning for multiple new product launches by verifying requirements and implementing quality-based procedures
- Acted as project quality lead ensuring alignment with EU GMP, ISO and internal regulations.
- Led cross-functional teams in the development and execution of quality assurance processes, resulting in higher customer satisfaction.
- Facilitated effective communication between departments regarding quality concerns, fostering collaboration towards shared goals.
- Monitored key business risks and established risk management procedures.
Quality Leader – CMO Management
Farabi Pharmaceutical
03.2021 - 03.2023
- Improved quality processes for increased efficiency and effectiveness.
- Collaborated with suppliers to improve material quality, reducing defects and increasing product reliability.
- Managed corrective action plans for identified non-conformances during internal audits, ensuring timely resolution and prevention of recurrence.
- Evaluated quality problems and performed assessments to identify and resolve issues.
- Wrote and implemented new procedures to validate processes and new products manufacturing flows.
- Managed and archived quality documentation and participated in internal and external quality audits.
QA Manager - CMO Management
Bionorica
08.2018 - 03.2021
- Developed and implemented integrated quality system among the affiliate to ensure highly regulated procedures and increase project success.
- Continuously monitored and controlled project plan to ensure alignment with business goals and strategies.
- Managed cross-functional teams to ensure seamless coordination between CMOs, QA, supply chain and regulatory department.
- Conducted investigations on occurred deviations and root cause analysis on recurring defects, implementing corrective measures to prevent future occurrences.
- Conducted comprehensive change management procedure among QA team and CMOs quality team to enhance manufacturing initiatives and prevent unplanned risks.
- Planned and conducted regularly internal inspections to detect in early stages incompliance and probable risks.
- Defined CAPA reports and followed up the implementation procedure.
- Conducted timely regular meetings with CMOs to ensure team alignment and maintain quality objectives.
- Prepared essential quality relevant documentation to lead processes in accordance with GxP standards.
- Oversaw the whole technology transfer process and conducted final report.
Technology Transfer Head - QA
Behestan Tolid Pharmaceuticals
10.2016 - 07.2018
- Led cross-functional teams to achieve company-wide goals of technology transfer of under-license manufactured products.
- Identified process weak points and implemented corrective actions to resolve concerns and improved quality.
- Overcame challenging deadlines and resource limitations by reallocating personnel and re-prioritized tasks.
- Conducted weekly meetings among team and licensors to ensure alignment with project initiatives and quality compliances.
- Initiated and prepared process SOP and required process protocols and reports.
- Conducted gap analysis to ensure carefully early detection and planning of mutual transfer gaps.
- Continuously monitored the quality key indexes during the transfer procedure.
- Conducted training sessions in quality procedures, data integrity and risk assessment.
QA Expert - Manager
Behestan Pharmaceutical
10.2013 - 10.2016
- Managed and motivated team to be productive and engaged in work.
- Accomplished multiple tasks within established timeframes.
- Maximized performance by monitoring daily activities and mentoring team members.
- Enhanced licensors satisfaction by resolving deviations promptly, maintaining regular communication and ensuring high-quality process delivery.
- Implemented feedback loops with other departments to continuously improve the quality of responses provided by QA.
- Proactively identified gaps in existing content and worked with experts to develop new resources for users.
- Optimized internal workflows by reviewing risks, deviation and found root causes and implemented process improvement.
- Generated reports detailing findings and recommendations.
- Contributed to quality audits and maintained CAPA reports and follow ups to the full implementation of required actions.
- Frequently inspected organization areas to verify proper operation and compliance.
- Conducted and contributed in deviation, change, CAPA, audit and validation processes.
- directed oversee on validation/ qualification processes and CSV.
- Participated in regular training sessions to stay updated on industry trends and emerging technologies.
Education
Bachelor of Science - Computer Software Engineering
Islamic Azad University
Tehran 04.2001 -
Skills
Project management
Software
Microsoft Project
ERPs
Languages
English
Advanced (C1)
German
Upper intermediate (B2)
Persian
Bilingual or Proficient (C2)
Work Preference
Work Type
Full TimeWork Location
HybridImportant To Me
Company CulturePersonal development programsFlexible work hoursWork-life balanceHealthcare benefitsTimeline
CSV Project Leader
Cobel Darou Group
01.2024 - 12.2024
Quality Leader – CMO Oversight & Compliance
Daryan Salamat Pharma Group
07.2023 - 12.2024
Quality Leader – CMO Management
Farabi Pharmaceutical
03.2021 - 03.2023
QA Manager - CMO Management
Bionorica
08.2018 - 03.2021
Technology Transfer Head - QA
Behestan Tolid Pharmaceuticals
10.2016 - 07.2018
QA Expert - Manager
Behestan Pharmaceutical
10.2013 - 10.2016
Bachelor of Science - Computer Software Engineering
Islamic Azad University
04.2001 -
Similar Profiles
Mahsa AbbassiMahsa Abbassi
Senior HSE Officer at Cobel DarouSenior HSE Officer at Cobel Darou
Arash KianiArash Kiani
SC and Procurement Supervisor at Cobel DarouSC and Procurement Supervisor at Cobel Darou
Arun Mukalel RajankuttyArun Mukalel Rajankutty
Construction Supervisor at Cobel DrywallConstruction Supervisor at Cobel Drywall
Gabriel GarcíaGabriel García
Assistant Sound Engineer at Portstone StudiosAssistant Sound Engineer at Portstone Studios
Dipesh JanaDipesh Jana
Electrical Engineer at Mercury Engineering GmbHElectrical Engineer at Mercury Engineering GmbH