Quality Assurance Project Manager

UONIS ALGAEDI Phone: 514-***-**** E-mail: ********@*******.***

PROFILE

Over 15 years experience in GLP/GCP/GMP regulated environment

Strong understanding of Quality Assurance practices and procedures

Ability to monitor and track Potency Bioassays and bio-analytical projects

Good understanding of the clinical Trials studies and drug development

Experience in conducting audits of all phases and aspects of clinical trials

Technical knowledge of chromatographic and analytical techniques

Demonstrated problem-solving and decision-making skills

PHARMACEUTICAL EXPERIENCE

Theratechnologies Inc.

Sr. Scientist/Project Manager, (Aug/07-Jun/11)

Assessed CRO labs (North America and Europe) before initiating and during the projects

Managed biomarkers and immunoassay projects from work plan design to reporting of data

Monitored and trended QC data from validation and analytical projects for bioassays

Reviewed key project documentations and provided support on quality and technical issues

Supported OOS investigations and assessed appropriateness of corrective actions

Assisted with developing procedures and QC process

Ensured project compliance with regulations and guidelines

Performed site inspections during the project, reviewed raw data and evaluated CROs

Maintained project plans utilizing Project Management tools; Gantt charts and MS Project

Acted as a point of contact and managed all communications with the CRO’s project teams

Sanofi-Aventis, Laval, PQ

Specialist, GCP QA, (May/07-Feb/08)

Performed GCP audits of local clinical trials, CRO sites, internal processes and protocols

Audited bio-analytical labs for compliance with FDA and OECD guidelines

Issued audit reports, recommended corrective action and conducted follow-ups

Written reports to management on compliance status of external/internal audits

Evaluated impending GCP related regulations and industry standards

Written, reviewed and revised quality system procedures (SOPs)

Developed training materials and delivered GCP training as required

MDS Pharma Services, Montreal, PQ

Bioanalytical Principal Investigator (Oct/04-Feb/07)

Investigated and audited AA, ICP and ICP/MS analytical methods in to ensure that SOP’s are followed and the QC protocols for assigned test methods are met.

Ensured analytical work is in agreement with the study protocol

Effectively conducted investigations and reviews of ICP/MS, LC/MS and immunoassay data

Interacted and developed client specific strategies with Business Development

Efficiently facilitated the pre-study meeting within lab operation and inter-departments

Successfully coordinated the process flow of the projects to meet timelines

Prioritized the work of assigned clients

Acted on behalf of the Study Director overseeing the conduct of GLP studies

Responded to observations from internal and external QA audits

MDS Pharma Services, Montreal, PQ

Supervisor, Quality Assurance (Sep/97-Sep/04)

Designed and completed internal QA survey to enhance QA training program

Compiled and analyzed information to optimize the use of QA trending and monitoring tools

Evaluated and recommended changes to QA processes to different MDS sites

Analyzed audit findings for process improvement activities and SOP reviews

Supervised and reviewed auditors’ work on preclinical and clinical study records

Provided input on development of SOPs and training materials

Evaluated auditors performance and identified training needs

Served as in-house consultant on GLP/GCP/SOP issues

Conducted audits for clinical, bioanalytical and QC (GMP) laboratory facilities

MDS Pharma Services, Montreal, PQ

Quality Assurance Auditor (Nov/95-Sept/97)

Carried out facility and study-specific inspections in the clinic and the laboratory

Performed site inspections for equipments, freezers, archiving facility and pharmacy

Reviewed pre-clinical and clinical raw data, included HPLC, LCMS and AA data reviews

Audited clinical, Bio-analytical and PK reports for animal and clinical studies

Produced written report at the end of audit/inspection listing findings/ recommendations

Discussed audit observations/findings with QA management and lab/clinical management

ANALYTICAL RESEARCH / TEACHING EXPERIENCE

Ministry of Environment & Energy, Kingston, ON

Lab Instructor/Research Scientist (May/95-Aug/95)

Performed routine analysis on water samples using AAS standard methods

Handled client request in the AAS department

Carried out daily instrument maintenance

Reported data using LIMS system

Chemistry Department, Queen's University, Kingston, ON

Teaching & Research Assistant (Sept/93 to Aug/94)

Developed test method for precious metals analysis using ICP-MS.

Conducted research to validate analysis of precious metals in samples, recovered from INCO mines, using ICP-MS techniques

Supervised undergraduate students laboratory experiments

Geoscience Laboratories, Ministry of Northern Development and Mines, Sudbury, ON

Lab Scientist (May/93 to Aug/93)

Carried out routine metal analysis for geological samples by XRF and ICP analytical methods

Conducted sample preparation using press pellets techniques for XRF analysis.

Carried out sample preparation for AAS & ICP analysis using hotplate and microwave digestion methods

EDUCATION

Master of Science in Analytical Chemistry, Laurentian University (1993)

Bachelor of Science in Chemistry (Honors), Laurentian University (1990)

PROFESSIONAL TRAINING / SIMINARS

Good Clinical Practice and Good Laboratory Practice

Compliance with FDA 21CFR Part 11

Dealing with FDA Inspections

Good Manufacturing/Laboratory Practices

FDA Inspection Process

Introduction to LC/MS systems

Validation of Computer and Software Systems

Analytical Method Validation & Instrumentation Qualification

COMPUTER KNOWLEDGE

Microsoft Office Suite (Word, Excel, Power Point), MS Project

Watson, laboratory information management system (LIMS)

Antelope, SoftMax Pro, Chromatogram analysis softwares

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