Syed Abdullah

Manager Validation Systems @Civica Rx

Lancaster, PA, US
EMAILS
s••••••••@civicarx.org
MOBILE NUMBERS
+18•••••••27

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WORK HISTORY

Jan 2024 — Present

Manager Validation Systems @Civica Rx

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EDUCATION

2005 — 2007

New Jersey Institute of Technology

M.S., Chemical Engineering

SKILLS

Change ControlQuality ControlGmpGamp21 Cfr Part 11Technical WritingGxpAseptic ProcessingCapaBiotechnologyBiopharmaceuticalsQuality SystemV&VRoot Cause AnalysisComputer System ValidationQuality ManagementSopFdaTrackwiseQuality AssuranceValidationCleaning Validation

ABOUT SYED ABDULLAH

Quality/Validation Leader with experience in the successful management and co-ordination of critical consent decree and pandemic covid/flu adjuvant vaccines cGMP biotech/pharmaceutical projects. Expertise in people and project management, Data Governance, Data/Process mapping and Data Integrity, quality operations, sterility assurance, aseptic manufacturing, regulatory audits, quality systems, commissioning, qualification and validation. Strong inter-personal, analytical and problem solving skills with ability to lead diverse and inclusive cross functional teams, including greenfield start up and facility expansions settings. Detail-oriented and dedicated to ensuring the timely completion of projects that meet the quality and regulatory standards.Specialties: Biotech, Pharmaceuticals, People and Project Management, Data Governance and Data Integrity, Manufacturing and Analytical Systems Compliance, Change Controls (CCRs), Quality Systems, Quality Reviews, Root Cause Analysis, CAPA, deviation Investigation, Risk Assessment, Gap assessment and remediation, Standard Operating Procedures (SOPs), Commissioning, Qualification, Validation, Aseptic Process Simulation, Sterility Assurance, Media Fills, Airflow visualization, Smoke Studies, Technical Writing, Decommissioning, Engineering and Validation Lifecycle, Commissioning and Validation plans for Process, Equipment, Utilities, Facilities and Process.

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