Naveed Anjum Email & Phone Number

California, United States

- Responsible for quality compliance for implementation, re-validation and retrospective projects of GcP, GLP and GvP Systems.- Document quality assurance activities with internal reporting and audits.- Assist Quality group by tracking, documenting, and reporting quality levels.- Collaborated with the team to leverage quality policies and procedures to.

Performed Compliance Assessment of all IT Systems at the client; presented findings and remediation. Managed Change Control through approvals.

Foster City, California, United States

- Led and supported multiple work streams for "Data Integrity” related- risk assessments with externalpartners (CMO, CPO and CTLs).- Developed/ Updated DI Questionnaire covering all aspects of data governance/management/security,sent to partner(s), to reflect emerging FDA, MHRA and EU mandated DI requirement and quality trends((e.g., 21 CFR Part 11, 210.

Brisbane, California, United States

- Managing multiple QMS implementation as Quality Assurance personnel to ensure compliance with site requirements and procedures.- Implementation of eQMS SmartSolve System, a Saas (Software as a Service) solution to support Document Management and Change Management modules.- Vendor audit and draft final report (TraceLink & Scien Tek Software for iStability.

Berkeley, CA

- Implementation of Module QC into existing Dev@Com System to support acquisition, assessment and documentation ofevents and laboratory deviations within the Quality Control laboratories.- Provided UAT support for Werum Track & Trace (Local) to use serial numbers downloaded from Bayer CentralSerialization Database (Global) into packaging line controller..

Berkeley, CA

- Valued as individual contributor to Project Apollo to perform Data Integrity Assessment for ~250 QC Systems (Client Server, Stand-alone workstation, spreadsheets). Effectively handled multiple demands and competing deadlines. - Resolved ambiguity to streamline the DIA questionnaire to focus on key area. Revised questionnaires (Manufacturing & Laboratory.

San Francisco Bay Area

- Acted as QA/Validation Lead and Project Manager to lead and manage validation activities of varying complexity including Enterprise-wide, Pharmacovigilance and Drug Safety projects.- Provided strong validation direction to internal and external project team members. Provided validation operations support for IT, Clinical, Regulatory, Supply Chain and.

Berkeley, CA

- Implemented ValGenesis 3.0 and supported LIMS LABVANTAGE 6.0 upgrade projects.- Global SAP Project (SAP Go4One). Streamlined existing Berkeley Business Process into the existing Global Bayer mySAP ERP P2R System. - Managed and responsible for resources, deliverable and timelines. - Liaison between the global team (Germany) and Berkeley business (Process.

(EMV & BRKL)

- Acted as ‘Validation Lead’ for both sites. Successfully completed multiple global and site-specific projects. - Provided validation support for global IT system transition from TOPAS SOP System to SCORE System. Migration of documents (~2500) from TOPAS into SCORE using sampling plans from ANZI Z1.4 guidelines.- Mentored less experienced team members in.

San Dimas, CA

- Acted as quality lead during integration of new sites to the global Oracle system (formerly JD Edwards). - Reviewed executed protocols for quality standards, traced requirements to the testing, worked with the user community to finalize execution. Modules tested were Sales & Distribution, Material Management/Planning and Plant Maintenance. Developed.

Emeryville, CA

- Acted as the quality lead for NVS Betaseron divestiture project, which included delivery by Novartis of an SAP system to Bayer HC that supports the operations for products being transitioned. - Quality representative to review and approve the strategy and approach that was used to separate SAP functionality from the NVS Production system and provide a.

Orange County, California Area

- Project lead in the conversion of Research and Development (R&D) laboratories into GMP areas. - Decommissioned legacy systems. Addressed compliance gaps and remediate systems to current regulatory requirements. - Managed several projects concurrently and met all project budgets and timelines.

South San Francisco, CA

South San Francisco, CA

Validation of SAP R/3 system, Plant Maintenance Module.

Validated an Enterprise Resource Planning (ERP) system. Supervised the test execution team, reviewed the business process procedure.

- Validated a JD Edwards Enterprise Resource Planning (ERP) System. - Established and streamlined test scripts for various GMP modules (purchasing, manufacturing, and address book). Supervised test script execution.