Zinia Azad
Quality Consultant Change Control @Regeneron
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WORK HISTORY
Quality Consultant Change Control @Regeneron
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
Seneca College of Applied Arts and Technology
Language Certificate
University of Toronto
Bachelor of Science - BS
Seneca College of Applied Arts and Technology
Post Grad
SKILLS
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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