Zinia Azad

Quality Consultant Change Control @Regeneron

Toronto, ON, CA
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

May 2022 — Present

Quality Consultant Change Control @Regeneron

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Rensselaer, NY, US

Conduct functional analysis of change control records per established procedure, provide in-depth analysis and holistic review of records to ensure they comply with internal processes and regulatory requirements.

EDUCATION

2012 — 2019

Seneca College of Applied Arts and Technology

Language Certificate

2005 — 2010

University of Toronto

Bachelor of Science - BS

2011 — 2011

Seneca College of Applied Arts and Technology

Post Grad

SKILLS

CapaDocumentationSopMicrosoft WordPharmaceutical IndustryGovernmentLaboratory Information Management System (Lims)LifesciencesWordStandard Operating Procedure (Sop)Policy AnalysisExcelGovernment ComplianceIch GuidelinesMicrosoft OfficeWritingChange ControlSoftware DocumentationAccessRegulatory RequirementsEctdBiotechnologyRegulatory AffairsAdministrationBatch RecordsQuality AssurancePowerpointMicrosoft ExcelPolicyLife SciencesGmpLimsBatch ReleaseDeviationsDeviationImpact AnalysisApqrProblem SolvingComplaintsGxp

ABOUT ZINIA AZAD

Experienced Pharmaceutical QA/RA professional in analyzing components of Quality Systems ( including product release, complaints and non-conformance investigations, production records, validation, stability, label compliance) •Effective team player with extensive experience working in intra and interdepartmental team in identifying root cause of critical and non-critical complaints and non-conformances, addressing audit observations, identifying and implementing corrective actions •Extensive qualifications achieved through over 10 years of multidimensional experience in various facets of the industry including liquid and solid-dosage drugs, biologics, NHPs, medical devices and controlled substance. •Skilled as an auditor ( self-inspection) and auditee to identify compliance gaps through holistic reviews, critical and innovative thinker to devise practical compliance-driven solutions •Proficient in all MS Office applications,MS Outlook, MS Project, pharmaceutical inventory and Quality System management software proficiency includes Trackwise, SAP, Docushare, JDE, LMS, Footprint, LIMS.

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Zinia Azad — Quality Consultant Change Control at Regeneron in Toronto, ON, CA | Unifers