Syed Abdullah
Manager Validation Systems @Civica Rx
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WORK HISTORY
Manager Validation Systems @Civica Rx
EDUCATION
New Jersey Institute of Technology
M.S., Chemical Engineering
SKILLS
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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