Sr. Document Control Specilaist
Resume:
MUJDE TULIN EVIZI
Senior Documentation Control Specialist
*******@*****.***
San Diego, CA 91910
https://www.linkedin.com/in/tulinevizi
EDUCATION
Ankara University
Turkiye
Bachelor of Science: Chemistry
SKILLS
Quality Assurance: Change Control, CAPA, Deviation Management, Root Cause Analysis, Risk Assessment, KPI Reporting, Internal Audits, External Audits, Gap Analysis, Data Integrity, ALCOA principles, OOS, OOT.
Regulatory Affairs: 21 CFR Part 11, 21 CFR 210 & 211, 21 CFR 600, ICH Q7, ICH Q10, ISO 13485. NDA
Document Management: Veeva Vault Docs, Documentum, EDMS, ComplianceWire LMS, Box, Document Life cycle Management.
Pharmaceutical Operations: API, Drug Products, Batch Records, Stability Testing, Manufacturing Processes, Batch Record Review, Process Improvement, Trend Analysis, GMP Manufacturing Batches, QC Test Records, Data Verification.
Software Proficiency: Microsoft Word, Excel, Access, Office, SharePoint, ShareFile. Adobe Acrobat,
LANGUAGES: English (Native), Spanish (Conversational), Turkish (Native).
CERTIFICATIONS
Regulatory Affairs Certification, Quality Assurance & Control Certification Drug Manufacturing, UCSD.
Pharmaceutical Laboratory and Sciences Certification, Southwestern College.
Advanced Project Management Certification, San Diego Continuing Education.
Regulatory Affairs Certification, Medical Devices, US-FDA, EU-EMA, SDRAN.
PROFESSIONAL SUMMARY
Quality Assurance and Document Control Specialist with over 8 years of experience in FDA-regulated pharmaceutical sectors; proficient in GxP compliance and document management systems like VeevaVault. Improved document review timelines by 35% at Bristol Myers Squibb while achieving zero major findings during regulatory inspections. Led successful migration projects at Celgene Corporation that resulted in 99% data integrity and enhanced compliance across system transitions, directly impacting audit outcomes and regulatory success.
WORK HISTORY
Creo Consulting - Dyne Therapeutics -Boston, Remote
Sr. Quality Systems & Training Specialist
San Diego, CA • 09/2024 - 01/2025
Administered Veeva Vault EDMS and Compliance Wire LMS ensuring compliance with 21 CFR Part 11 and company SOPs
Orchestrated the lifecycle of 500+ GxP document review and approval workflow within Veeva Vault EDMS including drafting, formatting, ensuring timely completion, compliance, and proper reviewer assignments.
Delivered GxP training on Veeva Suites and ComplianceWire to 30+ new hires monthly, enabling efficient onboarding, role-based training assignments.
Spearheaded the change management process, execution of periodic reviews for GxP documents within VeevaEDMS while monitoring implementation progress to ensure compliance and timely execution within Veeva EDMS.
Developed comprehensive training compliance trackers and audit-ready documentation, and increased GxP training completion rate by 40%, which fortified regulatory inspection preparedness.
Conducted internal audits, ensuring compliance with GMP and GDP guidelines and identifying areas for process improvement. Participated in external audits of vendors and suppliers
Fortified regulatory inspection preparedness by developing comprehensive training compliance trackers and audit-ready documentation, resulting in zero major FDA 483 observations during the FDA inspections.
Turning Point Therapeutics - Bristol Myers Squibb
Sr. Quality Assurance Specialist
San Diego, CA • 08/2020 - 06/2023
Facilitated the Change Control Review Board across departments from project start to finish, guaranteeing GxP vendor documentation and readiness for inspections, and maintained adherence to industry practices.
Orchestrated the review of over 2,500 QA documents and finalized more than 7,000 GxP documents, including DS and DP specifications and batch records, within CMC, GMP, GCP, and GLP environments, while coordinating a gap analysis that contributed to PAI readiness.
Examined deviation reports, CAPAs, and non-compliance documents, ensuring adherence to GxP regulations and minimizing potential audit findings that resulted in zero critical observations during FDA inspections.
Formulated quality metrics and presented key performance indicators at monthly quality meetings, resulting in a 35% improvement in document review and closure timelines for investigational materials.
Developed an efficient document review process in SharePoint, resulting in a 25% reduction in turnaround time for critical documentation and enhanced cross-functional collaboration with CMOs and CROs.
Collaborated with cross-functional teams on development projects involving biotechnological innovations aimed at treating complex diseases; streamlined documentation procedures, including updates to BOMs and ERP systems, enhancing efficiency by 30% throughout the project lifecycle.
Celgene Corporation - Bristol Myers Squibb
Quality Systems, Document Control & Training Specialist-Veeva Implementation
San Diego, CA • 01/2017 - 05/2019
Led the document mapping, implementation, and verification of a migration project from Documentum to VeevaVault software, ensuring compliance with Federal Regulations and International Standards, achieving 99% data integrity and enhancing compliance during system transitions.
Coordinated SOPs (standard operating procedures) and WIs development for approval in Veeva Docs, ensuring compliance with training requirements and implementing a robust Change Control process for SOPs updates.
Created GxP training programs in Compliance Wire LMS, set up user accounts, assigned training roles for new hires, and trained employees for Veeva Docs.
Spearheaded the digitization of 1300+ vendor documents within Veeva Docs, establishing a centralized repository that streamlined document control processes to meet regulatory standards.
Directed stability projects for APIs and Drug Products for completeness and bulk migration.
Intercept Pharmaceuticals Clinical QA Specialist, Document Control (Contract)
San Diego, CA • 06/2016 - 09/2016
Expedited the resolution of 50+ batch record discrepancies by mediating between Quality Control and Manufacturing teams, maintaining Batch Record history within the Veeva EDMS to support audits.
Administered the vendor quality document lifecycle for 25+ external suppliers, collaborating with cross-functional teams to ensure compliance with cGMP standards, addressing Validations and Corrective/Preventive Action Requests and adherence to document control procedures.
Vital Therapies
Quality Specialist- Data Integrity
San Diego, CA • 01/2015 - 09/2015
Company Overview: Medical Device- Biologicals- Cell Therapy
Created a batch records database by coordinating GMP manufacturing batches and QC test records with cross-functional team members and completed data integrity for continuous improvement.
Forged robust data verification processes supporting FDA BLA submission involving three clinical trials, consulting with Regulatory CMC, Quality Assurance, and R&D leadership, and reduced data errors by 15%.
Audited 110 Biological Batch Records and clinical documents, from historical to current, for regulatory submissions.
Bastas Barite Industry
Quality Control Manager
Antalya, Türkiye • 01/2013 - 01/2015
Managed quality control operations, reducing defects and improving overall product consistency and profitability by $500K.
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