Senior QA - Document Control Leader with GMP Expertise
Resume:
Alias Kooran
************@*****.***
Philadelphia, PA 19115
Phone: 215-***-****
Objective: Searching for a position with an that will showcase my skills and allow me to experience leadership with a positive attitude and fulfill my determination to continually improve. Professional Experience:
Quotient Sciences, Boothwyn, Pennsylvania December 2022 – July 2024 Sr. Quality Assurances Specialist
Provide QA support to the project
Review and approve manufacturing records and supporting documentation.
Review Executed Batch Manufacturing Records.
Create and issue Certificate of Compliance and release the batch Frontida BioPharm Inc. / URL Pharma, Inc., Philadelphia March 2009 – December 2022 Document Control Supervisor
Supervise the activities of Document Control personnel.
Monitor the accuracy, completeness, and timeliness of activities within the department
Manage GMP document generation, revision, issuance, retention, retrieval storage in the electronic Documentation Management System (EDMS)
Reviewing all documents in Change Control to include correctness and required approvals for Standard Operating Procedures, Protocols, Method of Testing, Master Formula Records and Validation / Qualification documents.
Support inspections for regulatory audits
Create /revise Standard Operating Procedure as required
Review Quality Control Analytical documents for Change Control process.
Prioritizes and schedules the day-to day activities in Document control
Successfully completed the migration of SOPs and Protocols from PharmaReady DMS to MasterControl EQMS.
Track documents and issue tasks, reminders, etc. to the responsible individuals to achieve prompt completion of the documents being processed
Checks on and assists the group, fills-in for them if necessary, and whatever it takes to meet deadlines.
Successfully completed the migration of SOPs and Protocols from the paper system to PharmaReady DMS.
Prepare various management information reports
Train new employees.
Assist personnel from other departments in their documentation needs. Page 2 of 3
Walks people through the Document Change Control process.
Successfully introduced the procedure for Issuance and Tracking of Logbooks for the GMP equipment and rooms.
URL Pharma, Inc., Philadelphia June 2004 – Feb.2009 Document Control Associate
Process, revise. Track and retrieve Standard Operating Procedure
Issue Batch Manufacturing Records to production and keeping track of it
Issuing logbooks for different departments
Facilitating the routing and communication to appropriate departments for expediting high priority change controls needed for production
Provided reports and documents per audit requests, both internal and FDA
Process, distribute and file Raw Material and Finished Product Test Methods & Analytical Reports
Issue and track process Temporary Process Deviation
File, archive and retrieve various documents
Distribute new/revised SOPs and indexes
Make SOPs/ Methods & Specifications effective and supersede the old copies
Prepare Certificate of Analysis for customers upon request
Update Record retention database
Prepare various management information reports
Supply Regulatory Affairs with methods and analytical reports and MFR’s for annual reviews. Log and distribute deviations. Issue and track change control numbers for MFR’s
Managed documentation including the issue of change control numbers for controlled documents i.e., SOP’s, MFR’s, methods and analytical reports.
Maintained SOP Index.
Maintain a database of documents in change control.
Distributed approved methods and analytical reports and supersede obsolete documents for version control.
URL Pharma, Inc., Philadelphia Sept.2003 – May.2004 Machine Operator
Operation of Collect Mixer, Glen Mixer and Gemco Blender- 20cu ft. 40 cu ft & 75 cu ft.
Operation of Gruenberg Oven and Harvesting of Oven
Operation of Fitz Mill, Alexanderwerk Milling Machine and Lightnin Mixer
Weighing of Raw Materials using Electronic Scales
Operation Purified Water system
Handling of Controlled Substances
Documentation Batch Manufacturing Record
GULF AIR DUTY FREE, Bahrain, Arabian Gulf April 1997 – April 2003 Inventory Controller
Receiving and verifying of all inventory
Preparing Stock Receipt Document and checking the same with the Purchase Order placed
Report on damages and discrepancy
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Submitting weekly stock report to user departments
Preparing management reports on slow/non-moving stocks
Sales Invoicing and timely deliveries
Product pricing and maintaining Product Master List
Review of order request from user departments
Preparation of Purchase Order and follow-up
Periodic Stock Reconciliation
Preparing Management Information Reports pertains to sales and stock holding
Monthly stock consumption report to suppliers
Data entry in Trade System 2000 for Integrated Inventory and Management Information System EDUCATION
Bachelor of Science in Chemistry: Gandhiji University, Kerala, India
Diploma in Computer Business Management: Talent Academy of Technology, India Proficient in Microsoft Office, including Microsoft Word, Excel, PowerPoint, Outlook etc. Good working knowledge in MasterControl EQMS, PharmaReady DMS, Veeva, TrackWise and ComplianceWire. Strong understanding of quality systems fundamentals of document management process and procedures. Clear understanding of cGMPs.
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