Robert J. Austin-LaFrance (acy6yu@r.postjobfree.com)

** ******* *****, ******, ** 06340; 860-***-****)

Education:

Trinity College, Hartford, CT. Neuroscience

Tulane University, New Orleans, LA. Biomedical Engieering

Northfield-Mt. Hermon School, Northfield, MA

Aug. 2016 - Jan. 2017: Alexion Pharmaceuticals - IT Validation Specialist, Global Regulatory Compliance. Intimate working knowledge of GAMP, 21 CFR Parts 11, 50, 56, 210, 211; ICH 7a & 7b, ISO 9011 and EMEA regulations and guidances covering GxP compliance.

Recent projects include GxP validation, migration and/or enhancement to:

1.Watson LIMS – global implementation for Bioanalytical verification of drug products.

2.Rave – Validation of MeDRA Coder functions.

3.OBA Information Request Management System – Creation of division EMEA to respond medical information queries in the UK. Implementation of Data Protection Rules for IRMS division EMEA; activation of QA Rules within IRMS division U.S.

4.Argus Safety – Author/Reviewer IQ and OPQ test scripts for implementation by Japanese affiliate.

5.Data Sciences International – Project coordinator - Global implementation of Ponemah P3 Telemetered Data Acquisition/Analysis systems (ECG & EEG).

6.Development of Audit Preparedness program.

Experience with all aspects of GxP systems validation across the entire SDLC spectrum: Initiation of Change Control, Risk Assessment/Mitigation and Vendor Certification; delineation of Specifications (FS, DS, URS, CS), development of Validation Plans, Protocols and Traceability Matrix; author, review, execute and approve Qualification Testing Documents (IQ, OQ, PQ test scripts), Security, Infrastructure and CFR Part 11 testing; discrepancy/resolution reporting, CAPA programming, root cause analysis, Business Continuity Planning; development of global SOPs, user manuals and GDP training; Validation Summary Reports; documentation and data archival; system maintenance, decommissioning and retirement.

Proficient with Mac and Microsoft operating systems, Word, Excel, PowerPoint, Outlook, Skype, Prism, Acrobat, FirstDoc, TrackWise, Valgenesis, Box, Sharepoint, CDISC/SEND, Pristima

1997 – 2015: Pfizer, Inc. - Study Director/Principle Investigator, Preclinical Safety Pharmacology. Responsible for all aspects of GLP and exploratory cardiovascular and central nervous system safety evaluations in animal models ranging from rat to non-human primate. Recognized SME for evaluation of ECG and EEG records. Member Global SOP Committee. Experience includes development of safety strategy and initial study design and execution through preparation of audited reports in support of regulatory submissions. Track record of delivery within scheduled timelines while maintaining compliance with all applicable SOPs and regulatory guidances. History of effective interaction with key stakeholders scheduling, designing and executing projects. Creation and presentation of training and certification materials in support of regulatory compliance and enhancement of colleague skill sets.

1985 – 1997: Trinity College, - Senior Researcher – Depts. of Neuroscience and Biomedical Engineering. Oversaw all day-to-day laboratory activities associated with grant-supported research. Authored grant proposals, designed, performed and reported supported research as journal publications and presentations at scientific conferences. Taught surgical techniques, study design, data acquisition and analysis procedures, and statistical evaluation testing.

Curriculum vitae and references available upon request.