Saba SIDDIQUI
Clinical Project Quality Manager
Mumbai,MH
Summary
Diversified Clinical Quality Assurance Professional with a demonstrated history of auditing in the pharmaceutical industry in the areas of GCP, GCLP, Clinical Data Management, Biostatistics, Medical Writing, IVRS, Pharmacovigilance and Regulatory.
Demonstrated success in coordination Pre-Approval Inspections (PAI), routine and directed Health Authority inspections. Developed procedural document content to ensure regulatory and internal compliance.
Overview
19
19
years of professional experience
4
4
Certificates
Work History
Sr. Manager, Clinical Project Quality Manager
Sanofi Pasteur
EU & Asia-Pac Region
04.2013 - Current
- Clinical project quality manager, sanofi Pasteur (Vaccine Division of sanofi).
- Lead and coordinate GCP Pre-approval inspection (PAI) preparation activities in support of regulatory filings for EMA, FDA inspections.
- Verify adequate inspection readiness/preparedness activities in Clinical Development.
- Proactive approach in providing quality & continuous improvement support for global studies/projects.
- Plan, organize, and perform project related quality audits including compliance audits of CRO following ISO Quality standards, systems and clinical investigator sites for Phase 1 to Phase IV clinical trials.
- Collaborate to develop, manage, and implement Quality Audit Program using risk-based approach.
- Restructured methodology to create audit instructions to adapt to risk-based approach in remote and on-site audit by implementing different strategies.
- Provide actionable insights from quality and operational data analysis and proactively works with clinical team to develop action plans to drive continuous improvement.
- Verify that quality system addresses quality risks both retrospectively and prospectively through deviation management, root cause analysis and Quality Risk Management.
- Effectively communicate risks to management, both orally and in writing.
- Manage cases of scientific misconduct and Serious GCP noncompliance including practice of early detection, timely escalation and resolution on on-going basis.
- Lead continuous improvement activities and conduct internal training on Quality standards and regulations.
- Develop or contribute to periodic GCP quality reviews and annual quality review.
- Trained and mentored team in performing various CRO and system audits.
- At company level, review and provide inputs to WHO, EMA, Indian HA when open to comments.
Manager RA & QA
QED Pharmaceutical Services
04.2010 - 03.2013
- QA & Training, QED pharmaceutical services.
- Planned, developed, organized, conducted and followed-up audits planned for Phase I to III studies.
- Lead and conducted investigators’ sites, system, CROs, data management and pre-clinical & clinical laboratory audits.
- Ensured that audit results and other quality information are formally and consistently recorded and reported and that corrective actions/preventive actions have been requested and are documented effectively.
- Provided regulatory support to inter-departmental project teams.
- Coordinated the preparation of responses to questions and inquiries from health authorities and ensured that CMC, clinical amendments, and safety reports are completed and submitted in accordance with regulatory submission schedules and requisite regulations.
- Developed and provide training and maintain training records for all QED employees and contractors.
Associate RA & QA
Suven Life Sciences
08.2007 - 03.2010
- Suven Life sciences.
- Planned study / project-based audits, system-based audits, vendor audits, internal audits.
- QC database, processes, and documentation.
- Involved in study start-up process by performing User Acceptance.
- Testing (UAT) of the database, validation procedure testing and providing feedback to the clinical database programmers.
- Lead data management quality control data audits, and produce reports summarizing the audits and findings.
- Review documents created during the data management process to ensure adherence to SOPs, regulations, and guidelines.
- Prepared relevant documents as required by the quality assurance department.
Document Specialist (Clinical Research Assistant)
Pfizer
01.2007 - 06.2007
- Thorough knowledge of electronic Trial Master File systems, processes, activities and clinical documentation and reporting.
- Responsible for document management of assigned clinical projects.
- Independently coordinated dispatch of prefiling documents and obtained regulatory documents from the site, with support from CSM or CRA as appropriate.
- Assisted Study Management in preparing regulatory applications and subsequent follow-ups.
- Responsible for coordinating with the sites for compilation of filing package documents with support from CRAs.
- Responsible for submission of regulatory packages to ensure drug release.
- Set up the e-Trial Master File and maintained compliance with ICH GCP and SOPs.
- Assisted in preparation of newsletters and other study-related documents.
- Maintained / assisted tracking spreadsheets for study-related data, tasks, and activities.
Retail Pharmacist
Medicare Pharmacy
04.2001 - 12.2005
Trainee
Hoechst Marion Roussel
10.1997 - 12.1997
- Training in different departments of manufacturing unit such as injectable, solid dose manufacturing unit, filling unit, packaging unit, QC & QA unit and warehouse.
Education
MBA - Quality Management
BITS Pilani
Post Graduate Diploma - Clinical Research
Bombay College of Pharmacy
Bachelor in Pharmacy - Pharmacy
Pune University
Diploma in Pharmacy - Pharmacy
Board of Technical Examination, MH
Skills
Inspection Readiness / Preparedness
ISO 9001-2015 internal & vendor Audits
Quality Management System
Quality Review
Continuous Improvement
Quality Risk Management
Project Management
Deviation Management
Quality / GxP Training
Certification
ASQ-CMQ/OE: ASQ Certified Manager of Quality/Organizational Excellence, American Society for Quality
Timeline
ASQ-CMQ/OE: ASQ Certified Manager of Quality/Organizational Excellence, American Society for Quality
12-2024
ASQ-CQA: ASQ Certified Quality Auditor, American Society for Quality
12-2024
SQA RQAP-GCP: Registered Quality Assurance Professional-Good Clinical Practice, Society of Quality Assurance
12-2023
Sr. Manager, Clinical Project Quality Manager
Sanofi Pasteur
04.2013 - Current
Manager RA & QA
QED Pharmaceutical Services
04.2010 - 03.2013
Associate RA & QA
Suven Life Sciences
08.2007 - 03.2010
Document Specialist (Clinical Research Assistant)
Pfizer
01.2007 - 06.2007
Retail Pharmacist
Medicare Pharmacy
04.2001 - 12.2005
Trainee
Hoechst Marion Roussel
10.1997 - 12.1997
MBA - Quality Management
BITS Pilani
Post Graduate Diploma - Clinical Research
Bombay College of Pharmacy
Bachelor in Pharmacy - Pharmacy
Pune University
Diploma in Pharmacy - Pharmacy
Board of Technical Examination, MH
Tools
- Veeva Vault Clinical
- Veeva Vault RIM
- iMedidata RAVE
- IMPACT CTMS
- ARMADA
- EnCore
- Castor eTMF
- XGRID
- Trackwise
- Phenix
- Access Management: UMAP, CSAM, eDentity
Quality Project Lead for Global Vaccine Projects
Meningococcal vaccine (MenQuadFi, Menactra), Covid (Recombinant vaccine), Rabies (Imovax, verorab, VrVg), Flu vaccines (FLU Quadrivalent HD, Vaxigrip Tetra), Pentavalent Vaccine (SHAN5), Hexavalent vaccine (SHAN6), Cholera (Shanchol), Rotavirus, HPV, Hepatitis A (Shanvac A, Avaxim).