Validation Consultant	Over 6 years of Experience in Pharmaceutical Industry working as a Validation Analyst in Validating the Clinical Data Management applications, Adverse Event Reporting Systems, (AERS) Laboratory Information Management applications (LIMS), SAS, and Electronic Document Management systems (EDMS) applications in Compliance with all the GCP, GLP, GMP and 21 CFR PART 11 Rules.  Experienced in writing and reviewing the documentation for computer Systems Validation life cycle (VLC), Content Management to comply with FDA regulation, particularly 21CFR Part11, including SOPs, IQ, OQ, PQ Protocols, Validation Summary Report.
Computer Validation Consultant	Over 5 years of experience in Pharmaceutical Industry with emphasis on Validation and Quality Assurance. Good working knowledge of 21 CFR Part 820 (QS Reg for Medical Devices), 601/610 (GMP for Biologics), 210/211 (GMP for Finished Pharmaceuticals), and 21 CFR Part 11 (Electronic Signatures and Electronic Records). Experience in AQA Compliance, Design Validation (clinical trials), Design Controls, Design Transfer, DHF, QS Regulations, DMR/DHR, CAPA, NCR, Risk/hazard Analysis and Production and Process Controls. Certified in ADD WWLIMS, ThermoLIMS, cGMP, GCP and GLP.
Senior Quality Specialist	Over 20 years experience  in the Pharmaceutical industry with strong auditing  and regulatory experience: Report to Manager, Quality Compliance and Regulatory Responsibilities include Complaint Management and Internal Auditing Complaint Management – Review complaints for potential MDR/MDV reporting, prepare MDR and MDV reports for submission, coordinate and or conduct complaint investigation and close complaints. Responsible for complaint related customer follow-up and manage receipt and input of incoming complaints. Internal Auditing – Conduct internal audits, report audit findings, issue corrective action and track closure. Interface with all levels of management to achieve timely corrective/preventive action.
Quality Assurance Auditor	10 years experience in the Pharmaceutical industry, strong auditing and compliance experience. Audit internal processes for compliance to related SOPs & FDA regulation’s Perform external audits including but not limited to: Vendors, Equipment Manufacturing Companies, Filter Suppliers, Packaging Suppliers, Contract Manufacturers, Active Pharmaceutical Ingredients Manufactures, Contract Analytical Laboratories, Software Developers, Clinical Packagers, Toxicology Laboratories, etc.  All audits noted above where performed according to ASQ guidelines, ISO standards, GMP’s including 21 CFR part 11, GLP’s , and GCP’s. Approve all validation protocols for the Quality Assurance Department. Approve all procedures for the Quality Assurance Department. Generate audit questionnaires pertaining to related services / department
Clinical Project Manager	Thirteen years  Clinical Trials experience. Certified Project Management Professional Three years Clinical Research Coordinator experience at an academic institution Ten years Clinical Trials Sr. Project Manager experience in a central laboratory setting Clinical Research Professional Certificate holder (via intensive CRA training course) Expert knowledge of drug/device development process, including FDA regulations, ICH GCP guidelines and HIPAA Experience assisting new sales reps with contract generation and understanding of protocols Facility with data analysis/QC, query generation and query resolution Experience validating trial-specific databases and programming Proficient in use of Microsoft Office software (Project, Word, Excel, Access, PowerPoint) Superior verbal and written communication skills

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