Khaled Saifuddin
Clinical Quality Assurance Manager at CCL Clinical Systems | Brooklyn, New York, United States
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Khaled Saifuddin serves as the Clinical Quality Assurance Manager at CCL Clinical Systems, where he plays a pivotal role in ensuring the highest standards of quality and compliance within clinical operations. With a robust background in quality assurance, Khaled leads a dedicated team of over eight professionals, overseeing critical functions such as Clinical Label Batch disposition, investigation, and line clearance. His expertise extends to managing various quality assurance activities, including the review and approval of Change Control, Deviation, Non-Conformance, and Root Cause Analysis (RCA).
Khaled is the main host during regulatory audits, including those conducted by the FDA, NSF, and independent consultants, ensuring that all inspections and inquiries are handled with precision and professionalism. His role is crucial in maintaining compliance with Good Manufacturing Practices (GxP) and other regulatory standards, as he actively supports all agency-associated activities, including addressing 483s and notifications. As a certified ISO Lead Auditor, he is responsible for the release of Batch/Finished Clinical Labels, Packaging Components, and Incoming Clinical Booklet Labels, ensuring that every product meets stringent quality criteria before reaching the market.
Khaled's proficiency in Laboratory Information Management Systems (LIMS) and High-Performance Liquid Chromatography (HPLC) further enhances his ability to manage quality systems effectively. His commitment to risk assessment and the establishment of Key Performance Indicators (KPIs) drives continuous improvement within the organization. Through his leadership and expertise, Khaled Saifuddin is instrumental in fostering a culture of quality and compliance at CCL Clinical Systems, ultimately contributing to the success of clinical trials and the safety of patients.
Clinical Quality Assurance Manager at CCL Clinical Systems in October 2019 to Present
Quality Assurance Manager at KABCO Pharmaceuticals, Inc. in February 2013 to October 2019
Manager Quality Assurance at Glaxo Smith Kline Phrmcuticals in December 2005 to February 2013
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University of Chittagong, Master's degree, June 2026
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Regulatory Requirements
Laboratory Information Management System (LIMS)
Complaint Management
Corrective Actions
Quality System
Manufacturing Operations Management
GxP
Quality Management
Continuous Improvement
Microsoft Office
Interpersonal Communication
Failure Mode and Effects Analysis (FMEA)
5 Why
Change Management
Internal Audits
Lean Six Sigma
Strategic Planning
Master Control
GMP
Good Laboratory Practice (GLP)
High-Performance Liquid Chromatography (HPLC)
Quality Assurance
Pharmaceutical Industry
U.S. Food and Drug Administration (FDA)
Management
Project Management
Standard Operating Procedure (SOP)
Microsoft Word
Statistica
Statistical Process Control (SPC)
Leadership
Change Control
Corrective and Preventive Action (CAPA)
Deviation Management
Root Cause Analysis
Risk Assessment
Risk Management
KPI Reports
Key Performance Indicators
Fishbone Analysis
Design Failure Mode and Effect Analysis (DFMEA)
Operational Excellence
Computer System Validation
Validation
Audit
Annual Product Review
Complaint Investigations
Master Manufacturing Record
Batch Production Record
Quality Council
GLP
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What is Khaled Saifuddin email address?
Email Khaled Saifuddin at [email protected] and [email protected]. This email is the most updated Khaled Saifuddin's email found in 2026.
What is Khaled Saifuddin phone number?
Khaled Saifuddin phone number is 3477494290.
How to contact Khaled Saifuddin?
To contact Khaled Saifuddin send an email to [email protected] or [email protected]. If you want to call Khaled Saifuddin try calling on 3477494290. (updated on September 05, 2024)
What company does Khaled Saifuddin work for?
Khaled Saifuddin works for CCL Clinical Systems
What is Khaled Saifuddin's role at CCL Clinical Systems?
Khaled Saifuddin is Clinical Quality Assurance Manager
What industry does Khaled Saifuddin work in?
Khaled Saifuddin works in the Pharmaceuticals industry.
Khaled Saifuddin Email Addresses
Khaled Saifuddin Phone Numbers
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