MUJDE TULIN EVIZI

Greater San Diego Area, CA +1-619-***-**-** ad3ihx@r.postjobfree.com https://www.linkedin.com/in/tulinevizi

QA-Regulatory Affairs-Document Control Professional

Summary

Quality Assurance, Document Control, and Quality systems professional with 10+ years’ experience leveraging broad experience in FDA-regulated pharmaceutical, biomedical, and medical device industries. Demonstrated ability to apply problem-solving and organizational skills in the pharmaceutical and biotechnology industry while adapting to new technologies.

SKILLS

Document Management Training Regulatory Compliance QSM GDocP US, EU, CAN Regulations Quality Systems Regulation ICH Guidelines cGMP GxP 21CFR 210&211 21CFR11, ISO13485, 510K 21 CFR 820 21 CFR 600 Microsoft Word Excel Power Point Access Adobe Acrobat Pro DocuSign Share Point Box Zen QMS eDMS: Veeva Vault Docs, RIM Documentum MS Project Smart Sheet Data Analysis Troubleshooting RCA CAPA SOP Supply Chain Labeling & Packaging Excursions Budget Customer Service Internal and External Communication Management Leadership

Multilingual: English Spanish Turkish German

Regulatory Compliance, Flexible, flexibility, problem solving, problem solve, resilient.

PROFESSIONAL EXPERIENCE

Turning Point Therapeutics Bristol Myers Squibb, San Diego, CA Aug 2020 –Jun 2023

Quality Assurance / Sr. Document Control Specialist

Directed Change Control Review Board with a cross-functional team by assigning change control numbers, implementing, and routing change control documents for approval, and closing the change control process.

•Administered Change Control program with CMC, QA, and Regulatory team by reviewing, assessing, tracking, follow-up, and completing all change control documentation.

•Managed competing priorities CMC vendor documentation for review and approval within the QA and CMC teams for commercial product release.

•Monitored the quality events, deviation, and CAPA documents for completeness of investigations.

•Supervised Stability projects for APIs and Drug Products for NDA submission.

•Coordinated Gap analysis for PAI readiness project for CMC, GLP, and GCP documents, and supported internal and external audits and inspection readiness.

•Participated in the Vendor’s project meetings with CMC team members and other stakeholders to capture project timelines and all manufacturing activities and resources needed to deliver against corporate goals.

Turning Point Therapeutics, Subsidiary of BMS Aug 2020 –Jun 2023

Quality Specialist /Document Control Associate III

Collaborated with CMOs, CROs, GMP, GLP, GCP, and QA team to facilitate the review and approval of process development, analytical and manufacturing activities.

•Provided Clinical Study Reports, Protocols, Bioanalytical, DMPK, and Toxicology documents from CROs and made sure all versions were available in Archive folders.

•Connected (CROs), Contract Service Providers (CSPs), Bioanalytical Labs and Investigator Sites. Audited clinical protocols, ICFs, Clinical Investigator's Brochure, Clinical Study Report audits, and other clinical trial-specific documents.

•Managed controlled documents and records in QA cabinets and SharePoint and updated the document archive log for inspection readiness.

•Established organizational structure such as trackers, QA review log, and SharePoint folder for the GxP and QA team to optimize efficiency and performance.

•Processed 2500 QA Reviews, and managed more than 7000 GMP, GCP, and GLP documents in 2.5 years.

•Led the GXP team members in a fast-paced, matrix environment across multiple programs.

•Administered QA-GxP review meetings with CQA approvers to obtain the status of each document.

•Retrieved the effective documents from vendors, closed the review process, and sent Closed QA review reports weekly.

•Retained DocuSign certifications in the Archive folder for regulatory inspection.

•Combined effective documents with their approved documents with Acrobat Adobe Pro.

•Prepared documents for migration into the new Veeva Docs EDMS.

•Provided end-user system use training with Veeva, DocuSign, SharePoint, and the Quality Review process.

•Maintained databases and metrics, and managed document submission log and document archive log.

Sel directed, committed, attention to detail, Verbal communication, exceptional organizational skills

Celgene (former Receptos) QA Specialist, San Diego, CA Jan 2017 – May 2019

Quality Specialist/Document Control

Successfully coordinated and implemented a software migration project for GMP GLP, GCP. and Quality documents. Verified that the correct and complete data were transferred from the legacy (Documentum) to the new software system (Veeva Vault) during the Data Migration coordinated with IT and verified that all the documents were transferred to a new eDMS.

•Monitored data and identified issues related to Veeva Vault software and workflows.

• Supported mapping process for the migration of Veeva Vault.

•Created Saved Searches in eDMS and distributed to all departments.

•Ensured review, approval, and routing of Controlled / Managed documents and made sure current versions were available for use at Veeva eDMS. Coordinated, analyzed, and uploaded 1300 Vendor documents into Veeva eDMS in 2 years.

•Prepared and formatted SOPs, WPs, and Bridging Memos and maintained their binders and Master Indexes. Initiated required forms to process the documents through an electronic or paper-based document management system.

•Audited and ensured the correct use of templates, and correctly entered metadata and document types.

•Completed Periodic Review Reports, Aging Reports, and Effective and Obsolete Documents Reports periodically.

•Established the Open Change Notices table manually and ensured the timely implementation of document change requests.

Training

•Provided end-user system use training at Veeva Vault and Documentum eDMS.

•Created users and groups for new employees in Compliance Wire-LMS and assigned their training according to their responsibilities. Termed inactivated employees.

•Gathered employee CVs, Job descriptions, Signature records, and training records and entered them into the document repository. Uploaded Job descriptions into Veeva eDMS and obsoleted them when no longer needed.

•Tracked GxP employees’ digital signatures, consultant/contractor list, and training spreadsheets for inspection readiness.

Quality Assurance

•Compiled and reviewed EBRs, MBRs, and Gap Analysis, prepared Inventory for Clinical Trial documents, and archived Supplier Audit certifications.

•Analyzed CMC documents for the Bulk Migration Project and successfully migrated them into Veeva eDMS on time.

•Managed the Stability program and the Clinical Supply Chain department for preparing and reviewing CTM Label Text / Proof Packages and Temperature Excursions.

Intercept Pharmaceutical, San Diego, CA June 2016 - Sept 2016

Clinical QA Specialist Document Control

Performed Quality Assurance Batch record reviews including Raw Material Certificate, Certificate of Analysis, and Certificate of Release, and maintained logs of Product Disposition and API Batch Verification Checklist, Authorization of Ship under Quarantine, and other reports as needed.

•Ensured complete Batch Record history file is maintained in the Veeva Electronic Data Management System.

•Managed all document control activities in Veeva EDMS.

•Maintained vendor-supplied Quality Documents as part of the company’s Vendor management program including Deviations, CAPA, Quality Risk Assessments, Root Cause Analysis, and Change Controls.

•Gathered Deviation and Out of Specification (OOS) reports in manufacturing for investigation reports analyzed data and wrote summaries for Quality Assurance and Regulatory Affairs departments.

Vital Therapies, San Diego, CA Feb 2015 - Sept 2015

Medical Device-Biologics-Cell Therapy Quality Specialist-Consultant

Coordinated document (cGMP manufacturing batch records and QC test records) gathering activities among Document Control, Quality Control, Clinical, and Manufacturing personnel, reviewed for good documentation practice and completed data integrity project, and site inspection readiness activities.

•Designed and verified databases of in-process testing, final product release testing, and production process parameters for regulatory batch record analysis, and clinical trial tables/ figures/ listings.

•Presented findings on documentation discrepancies and deviations in manufacturing to the GMP department and made recommendations for continuous improvement processes and strategic thinking.

•Independently performed other data verification projects for FDA - BLA submission after discussing the objective of projects with Regulatory CMC, Quality Assurance, and R&D management.

•Led and oversaw new employees on data verification projects and internal audits and worked effectively with cross-functional teams.

•Reviewed Batch Records for combination products and tracked all lots from historical to present, GMP materials, Analytical data, Shipment verification, destinations, line clearances, Certificate of Analysis, and Sterility documents.

•Conducted a comparison of data recorded on Case Report Forms against source documents, verified Informed Consent Forms for accuracy and completeness, and reviewed regulatory documents and device accountability records. Issued, investigated, monitored data, and resolved data discrepancies. Ell therapy, biologics power point Drug development pharmaceutical industry

Bastas Barite Industry, Antalya / Türkiye Jan 2013-Jan 2015

Quality Control Manager 2 yrs

• Performed qualitative and quantitative analysis on incoming materials and reduced quality defects.

• Managed and trained cross-functional teams with 4 direct reports.

• Managed and supervised the Barite recovery project calculating profitability for the company saving $500K, budgeting and reducing turnbacks, quality defects, and escapes to customer

• Performed quality control tests daily and reported to senior management and improved quality by 35%

• Selected by executive management to represent the company during quality and internal audits.

Board Member – Director Board Member - Director

Travel Companies · 8 yrs Antalya, Turkey

•P&L responsibility and annual revenue for over $10MM with 15 direct reports

Education

Bachelor of Science, Chemistry

Ankara University, Turkey

Master of Education

Ankara University, Turkey

Pharmaceutical Laboratory and Sciences Certification

Southwestern College, Chula Vista

Quality Assurance and Control Certification

Drug Manufacturing University of California San Diego, (May 2020)

Regulatory Affairs Certification

for Drug Manufacturing UCSD (Aug 2021)

Project Management Certification

PMCP, San Diego Continuing Education

PROFESSIONAL DEVELOPMENT

SQL-Access Certification, SD Continuing Education

EU and Canadian Regulatory Affairs, RAC study course, SDRAN

SAP / ERP Certification, My Think Tree Technologies Training Organization

US Regulatory Affairs RAC study course, SDRAN

US and EU Regulatory Affairs RAC study course, SDRAN

Life Science Immersion Program, Certificate, San Diego State University Extension, San Diego

US Regulatory Affairs Course, Regulatory Affairs Professional Society, Wisconsin

PROFESSIONAL AFFILIATIONS & AWARDS

American Chemical Society

SDRAN

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