Masuma Anwar

Quality Management System and Regulatory Compliance professional In Pharmaceuticals and Clinical Research Organization. Expert in documentation, CAPA management, change control management, Root cause analysis, Risk Management, Market Complaints, Laboratory management, Qualification – Validation, Regulatory compliance and Audit. Audit readiness, monitor visit, Clinical and Pharmaceutical Quality Assurance.

Expert in Data Integrity guidance, start-up and implementation. Skilled in FDA guideline (GMP and GCP), PICS, ICH, ISO 9001, 13408, 13485, 14644, ICH, PICS, WHO, USP 71, 113, GAMP 5, and EU and MHRA regulations.

Steel industry: Key guidelines include the American Institute of Steel Construction (AISC) standards for design (AISC 360), detailing (AISC 341), and trade practices (AISC 303), ASTM specification, along with OSHA regulations for site safety, especially fall protection and proper rigging

Regulatory Compliance Specialist (CTO) - Augusta University - Augusta, GA 30912

(2024-08)

Led clinical trials management for multiple departments (like Cardiology, Rheumatology, Pulmonary, Neurology, Neurosurgery, Trauma, Oncology) projects.

• Developed SSU Dashboard to follow-up the project's activity and timeline. Lead the project meeting every week and set priority of action to complete the project on time. The dashboard I have developed its reflects all the necessary step, will show completion date as well as thruput time and real time.
• My core responsibility is to handle the project, documents management, archival and access control.
• Responsible for IRB submission and communication with Local and Central IRB.
• For the closeout project, I am responsible for reviewing the TMF for completion and compliance, then sending the file to Central archival facility of Augusta University.
• Responsible to manage Veeva Vault platform for project documentation including SOP, CV, Medical license, Training documents etc. and get the project ready for Inspection.
• Work closely with BIOSAFETY and RADIATION safety team to ensure research safety requirement.
• Ensure Quality compliance and perform quality inspection prior to Monitor visit.
• Build-up protocol, consent form and other relevant documents on-behalf of PI for PI initiated study.
• Prepare and submit regulatory package to FDA for New project approval for PI initiated study.
• Assist and collaborate with internal/external sponsors during regulatory compliance audits
• Performed Source Documents Review (SDR), Resolved Queries in Veeva Vault or Sponsors recommended Electronic Management System.
• Coordinate site qualification (SQV), initiation (SIV), monitoring (SMV) and Close-out visits (COV) for Phase II and Phase III clinical Trials for all other departments (e.g. Nephrology, Pulmonary, Cardiology, Rheumatology, Pediatrics, Neurology, Neurosurgery, GI, Vascular and all other department in Wellstar MCG Augusta)
• Provide training and Guidance to new research members.
• Responsible for collaborating and updating project related information to the study coordinator and other study team members as applicable.
• Involve in Redcap project for Institutional research management.

Manager Quality Management System specialist - OSTRO Steel Structure - GA

(2022-11 - 2024-05)

• Responsible for Quality System Management, Quality certification and Audit process.
• Process optimization, Lean project and active member of process improvement plan
• Quality Documentation, Training, Change control Management, CAPA Management, Deviation and Risk Management, Customer Complaint.
• Quality Agreement.
• Laboratory Management and equipment qualification, calibration, and access control.
• Materials Receive, analysis, and release, tracking, and traceability to end product.
• Responsible for training, developing training matrix and need, training calendar and individual training record.
• Elaborate the procedures of sampling and guidelines for collection and reporting quality data.
• Oversee the implementation and ensure efficiency of inspection and quality systems.
• Supplier qualification and monitoring.
• Software Handling: Quality Software for traceability and release, Fishbowl and Conex
• Preparation Protocol and report for Validation Qualification
• Responsible for Area mapping and transportation system validation

Manager Quality Assurance and Inspection Specialist - Cornucopia INC - GA

(2020-09 - 2022-11)

• Responsible for documentation generation, distribution, and control.
• Process analysis step by step, identify the critical control parameters, cpk calculation and root cause analysis.
• Responsible for the Quality lean projects, run QC circle,
• Laboratory management, equipment qualification and handling
• Handling Audit and Inspection
• Supplier qualification, evaluation and Monitoring.
• Elaborated the procedures of sampling and guidelines for collection and reporting quality data.
• Oversee the implementation and ensure efficiency of inspection and quality systems for continuous improvements.
• Planned, performed and overseen inspection and testing of products to ensure the quality deliverable.
• Initiated and resolved non-conformances, and deviations and involved in CAPA activities using TrackWise.
• Reviewed, and approved batch records and performed real-time review it the manufacturing operations and supervisors supporting documentation for completeness, accuracy and compliance.
• Reviewed, approved and handled Data Integrity Assessments, management, Data Handling, Records Identification, Application configurations, etc.,
• Handle regulatory audit from FDA, USDA, Primus and other regulatory authority.
• Reviewed and documented electronic Audit trails, retention period, ERES, data backup and data recovery.

Data Quality Specialist - True Tech - MI (Remote Contract)

(2017-10 - 2020-09)

Ensure Total Quality Management System and give documentation support for different pharmaceutical company (Project based)

• Review and approval of Dossier before registration
• Regulatory file review and submission
• Review Clinical trial documents before submission
• Change control management, Deviation Management, CAPA Management, Risk Management and also review effectiveness of CAPA and follow-up. Have online meeting to support the team until the CAPA closes. Review all relevant documents to ensure that the CAPA closed as per action plan listed.
• Quality Software management, data entry and ensure correctness of data.
• Support validation documentation, protocol development and report review.
• Risk management (Pre and Post)
• Product Quality review, and trend analysis yearly basis.
• Review Laboratory Machine, evaluation of system and requirement for replacement as GAMP-5 requirement
• Maintain access control and implementation of Data Integrity requirements as per ALCOA+

Head of Site Quality Ops - Sanofi Pharma - Bangladesh

(2014-11 - 2017-09)

Responsible for working on sterile (aseptic and Terminal sterilization) and non-sterile manufacturing processes for formulation of Betalactam, cephalosporin, general products including but not limited to Analytical, process, facility validation and qualification.

• Laboratory management including LIMS system, sample tracking and traceability, documentation, equipment qualification and calibration.
• Also responsible for clinical laboratory compliance, follow-up compliance to protocol, sample tracking system, data analysis, data evaluation before releasing the product for the commercial market
• Written and updated Qualification documents processes and utilities including media fill.
• Responsible for working on qualifications for facilities and utilities (WFI, gases, CIP, SIP and chemical compounds) in building modular clean rooms.
• Responsible for authoring, reviewing and approving qualification and validation documents like Validation plan, Installation Qualification, Operational Qualification, Performance Qualification and Test Method Validations for different equipment's.
• Written and routed process qualification non-conformance, deviations, CAPA management through Phoenix software etc.
• Plan, perform and oversee inspection and testing of products to ensure the quality deliverable.
• Writing, reviewing, updating and redlining procedures following Good Documentation Practices (GDP).
• Reviewing records and performing real-time reviews during validation of manufacturing operations and supporting documentation for completeness, accuracy and compliance.
• Performing gap analysis, and requirements gathering for projects with the vendor and cross-functional teams.
• Review and address the deviations associated with different issues across the platform.
• Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices.
• Track and trend data on a weekly basis to update the project timeline and daily work.
• Detect coaching needs and take actions in accordance with these needs to ensure compliance with quality standards.
• Oversee the implementation and ensure efficiency of inspection and quality system

Augusta University