AI in Healthcare
Data Analysis
JACK B. BROWN
5 STARGATE LANE CHESTER, NY 10918 H. 845-837-1325 C. 914-830-1341 E-mail zeeyaa@aol.com
Senior Manager with over 30 years of extensive Project, Quality, and Compliance.
Attn: Recruiter,
I offer 30 years of a successful background in Quality Assurance, Complia
....
nce, Clinical, Regulatory Affairs, and Project Management, as well as an education in Information Technology and life sciences. My experience has exposed me to many quality assurance and regulatory affairs aspects. This includes Medical Device, Aseptic Manufacturing, Product Management, developing SDLC processes, business specifications/requirements, CAPA/Complaint handling, writing, reviewing, approving, and executing policies, SOPs, and Protocols. Also, ensure that all projects meet client requirements and better expectations. I have successfully managed multiple projects in various industries, such as:
* Pharmaceutical products.
* Biotech/Medical devices.
* Combination Products.
* Consumer Products.
* Process Equipment.
* Building Facilities.
* Military Communication equipment.
* Plastic Injection/Thermoform molding.
* Electro-mechanical assemblies.
* Software Applications.
I have been responsible for creating, maintaining, and enforcing regulatory policies compliant with FDA, cGMP, QSR (21 CFR Part 820), (21 CFR 210,211), ISO 13485 EU, CE Marking, and CMC requirements. I have conducted many internal as well as supplier audits for significant companies and contract manufacturers. I have maintained customer complaints, investigations, CAPA, calibration, and environmental control systems. I managed the production and process controls and final product release. I provided quality updates for all outstanding issues and improvements being made.
* Lead Management Review Process and chaired executive meetings
* Provide supervision, maintenance, and regulatory guidance for audits performed by FDA, ISO, and European CE mark approvals.
* Direct Interface with principal investigators/auditors from clients and regulatory agencies such as FDA, ISO, and Health Canada
* Prepare and submit regulatory documents for approval of 510k, IDE, tech files, and Pre-Market Approvals for Class II and III products.
* Manage and direct all QA, RA, and Clinical personnel
* Conduct site training on procedures and protocols
* Develop validation protocols.
I have organized and managed a large number of support staff of various departments for large Bio/Pharm, Medical Device, CROs, and Contract Manufacturers. I have experience writing, reviewing, training, and executing SOPs, report packages, and validation protocols for Boston Scientific, Eisai, Inc., Pfizer, Schering Plough, Johnson & Johnson, and Proctor & Gamble. My knowledge of U.S. and E.U. Government Regulatory Agencies and other compliances are thorough, such as:
> GAMP, cGMP, GLP, GCP
> FDA, ICH, ISO 9000, ISO 13485, Shonin, 21 CFR Part 11, 820, TQM, SPC, IDE, NDA, PMA, MDD, MDR, 510k, and CE Certification
> Mil Specs, Underwriters Laboratory.
> URS, FRS, DS, Test Plan, Validation Plan, Traceability Matrix, IQ, OP, PQ, Validation Summary, and Change Control.
I am confident that I could implement my experience immediately and contribute to the success of any company. I need only a two-day notice for a phone and one week for a face-to-face interview. I could start a week after offer. If you have questions, please don’t hesitate to call.
Sincerely,
Jack B. Brown
c. 914-830-1341
h. 845-837-1325
Specialties
- Quality Assurance and Regulatory Affairs advisory for Pharmaceutical
- Biotechnology and Med-Tech/Medical Device areas.
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