Anwar Kamal
1976 Flagstaff Ct., Glendale Heights, IL 60139
313-575-5396 (cell)
[email protected]Summary: Over 22 years of experience in the field of Quality and Manufacturing
engineering.
Highlights:
• 2017 MDR gap assessment and Baxter QMS remediation activities.
• Contributed to organizations increase in business and created positive work
environment by driving continuous improvement goals and team efforts.
• Written Product Summary Reports on identified gaps and respective remediation
action as per FDA guidelines.
• Verified Packaging Commodity Changed Approval documents at Abbott
Diagnostics.
• Experience in modification of design plans.
• Hands on experience in manufacturing process trouble shooting, CAPA and
implementation of Lean Six Sigma practices.
Work Experience:
Takeda Pharmaceutical Company Round Lake, IL
Quality Associate July 2020 – November 2023
• Managed and maintained the overall Change Control (CC) process, administered CC
board meetings.
• Developed and delivered local training materials related to the Change Control process.
• Served as the site's Trackwise administrator, managed access for new and changing roles.
• Provided regular support and coaching on how to use Trackwise for change control
records execution.
• Successfully completed investigations of process related deviations.
• Ensured CAPA records were closed on time and implementations were effective.
• Actively participated in Value Ambassador program and supported Veeva management
activities.
• Drafted Failure Mode and Effects Analysis (FMEA) for proposed Change Controls
HCL America (Med. Device Reg. CoE) Round Lake, IL
Senior Tech. Lead (Client - Baxter) January 2018 – October, 2019
• Performed Devices labeling Gap Analysis to EU MDR 2017 requirements and provided
remediation guidance to management.
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• Drafted consolidated reviews reports and clarity on labeling content requirement to
management.
• Part of remediation project, redlined labels and submitted report.
• Led offshore team to ensure accuracy and completeness of analysis.
• Prepared QMS Plan for 2017/745 MDR gap assessment and initiated Baxter QMS
remediation activities.
• Assessed Baxter QMS against MDR requirements
• Identified Baxter GQM, GQR and GQP against MDR requirements
Fresenius Kabi Bensenville, IL
Provider of products ranges from intravenous specialty and generic medicines, transfusion
technologies, infusion therapies, clinical nutrition to related medical devices.
Logistics Analyst / Technical writer (contractor) April 2017 –September2017
• Documented Initial Impact Assessments and Final Deviation Reports on temperature
excursion during shipment.
• Analyzed temperature stability study provided by the supplier to support the temperature
excursion duration experienced by the product during shipment.
• Led continuous improvement initiatives.
Abbott Labs Lake Forest, IL
Provider of products ranges from nutrition and diagnostics to pharmaceutical therapy.
QA Specialist III May 2016 – November 2016
• Verified Packaging Commodity Changed Approval documents.
• Participated in the development and modification of validation packages; design plans;
and risk management deliverables.
• Participated in the development and modification of Risk management files.
Hospira (a Pfizer Company) Lake Forest, IL
World's leading provider of injectable drugs and infusion technologies.
Supplier CAPA Commitment Lead and Supplier Change Coordinator April 2015 – Dec. 2015
• Assured Supplier audit-related CAPA records are accurate, complete, compliant,
accessible and retrievable.
• Supported regulatory inspections through preparation, managed access to supplier quality
records in the TrackWise SQM, and SharePoint systems.
• Assembled the change package and processed supplier changes by reviewing the change
request for completeness, GDP and accuracy.
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Hospira Inc. Lake Forest, IL
Regulatory Remediation Analyst August 2014 – December 2014
• Reviewed remediation documentation for the identified requirement gaps for
microbiology, chemistry, regulatory and stability groups.
Baxter Healthcare Corporation Round Lake, IL
Manufacturer of various medical products
Validation Engineer February 2014 – August 2014
• Prepared Master Validation Plan and project status tracker.
• Executed gap analysis of devices test method validation requirements.
• Performed Validation activities for Medical devices. Updated Traceability Matrix.
• Identified test method type (visual, functional demonstration, compendia, attribute and
variable). Reviewed Design History Files.
Testimonial
Thanks for your support and guidance; it was a very good experience working with you. Renal PD is in a clear
path now which would not be possible without your right approach and continuous effort. Thanks!
Anandkannan P (HCL-Renal Team Lead Engineer)
Hospira Inc. Lake Forest, IL
Quality Engineer/Supplier CAPA Support May 2013 – December 2013
• Closed open device and Pharma suppliers audit CAPA plans part of CMP containment
control Plan.
• Assisted in two protocol implementations; supplier audit remediation.
• Manage supplier audit CAPA plans and ensure timely implementation and completion of
corrective actions.
Baxter Healthcare Corporation Round Lake, IL
Quality Engineer May 2011 – March 2013
• Completed the Renal complaint handling project successfully.
• Utilized DFMEA for new product launch.
• Reviewed customer complaints received for Medical Device Reports (MDR) at Baxter.
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Suzlon Wind Energy Corporation Chicago, IL
Suzlon is among the world leading wind power companies with more than billion dollars in
portfolio.
Quality Engineer October 2008 - August 2010
• Developed quality system documentation; performed internal audits of the Quality
Management System
• Improved product and process quality by applying Root Cause Analysis such as Pareto
Analysis, Fishbone Diagram, QFD, PFMEA and managed suppliers quality.
• Did the turbine break down/failure analysis at turbine site.
• Managed and written CAPAs on non-conformances.
G&W Electric Co. Blue Island, IL
Manufacturer of power transmission and distribution products
QA Admin. (MBAF) / ISO 9001 Systems Manager March 2005 - June 2008
• Managed the ISO 9001 auditing program and played lead auditor role.
• As a QA Admin. managed the Kaizen, continual improvement, COPQ reduction and
training programs; participated in Lean program.
• Developed visual work Instructions database (library) also accessible to shop floor
operators in real time at the point of use to get consistent and repeatable results.
• Trouble shooting of non-conformances at workstations.
• Managed and written CAPAs on non-conformances.
• Implemented Kaizen and Lean Manufacturing practices on work stations.
• Due to successful implementation of Lean Manufacturing practices profit margin
increased and achieved enhanced customer satisfaction.
• Participated in New Product Launch quality reviews.
LSL Industries Inc. Chicago, IL
Manager Quality Assurance /Regulatory Affairs /ISO Dec. 2003 - March 2005
• Led organization to ISO 13485 certification.
• Implemented Kaizen and Lean Manufacturing practices on workstations.
• Manufacturer of Medical Devices and Disposable kits
Education:
Wayne State University December 2002
Degree: Masters Major: Mechanical Engineering City: Detroit GPA: 3.3
Skills: Experienced Auditor for ISO 9001, 13485, 14971, 6-Sigma and Lean techniques.
Certified Lean Six Sigma Green Belt
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