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Chaher Soliman4746, Prvel
Pierrefonds, Qc H9K 1J4H: 514-620-0344, C: 514-653-0344
[email protected]
OBJECTIVEA senior management position in a pharmaceutical,
biopharmaceutical or cosmetic firm where my ampleexperience and
proven track record will contribute to improved efficiency and
increased productivity.
PROFILEFluently bilingual and highly qualified manager in plant
and quality operations. Excels in streamliningprocesses with a
lean, hands-on, value-added management approach. Professional with
vast experience,well versed in product development, quality and
global regulations. Resource person for all operational
andcompliance procedures and protocols. Champions projects to
fruition with multidisciplinary teams. Thrivesin a fast-paced
environment and consistently meets tight deadlines. Has an
analytical and pragmatic mindwith ability to seize the big picture.
Recognized planner, organizer, problem-solver, creative and
visionary.Instrumental in improved productivity and efficiency of
staff through expert training and coaching.Exceptional communicator
and a strong believer in team spirit and humour in the
workplace.
COMPUTER SKILLS & TECHNICAL KNOWLEDGE
Familiar with MS Windows XP environment as well as MRP system.
GMPs; GLPs; Technology Transfer; Change Control, IQ, OQ, PQ, HVAC,
and validation (as well as
CFR 21 Part 11); CMC, SUPAC, Annual Product Report/Review,
Product Master File, DMF, SOP writingand training, audit review; as
well as familiarity with NDS (& S/NDS), ANDS and IND; ample
knowledgeand experience in facility preparedness to Health Canada
or FDA inspections (e.g. conducting internalaudits and mock
inspections for plant readiness prior to FDAs PAIs).Strength in
complaints handlingand recall procedure, transport and storage
conditions, and other operational principles.
PROFESSIONAL EXPERIENCE
NAMILOS Pharma Consulting 2005 to presentFounder &Senior
Consultant
Provide Compliance, QA, Regulatory Affairs and varied services
to a wide range of clients in Pharma,cosmetics and NHP.
Major clients:
DRA Pharmedev Associate consultant (2005 to present, ongoing
assignments) Reviewed and evaluated product development work and
the associated global documentation. Reviewed and provided
recommendations regarding ongoing submissions pending approval,
such
as DMF, QOS, CMC, Master Production Documents and numerous SOPs
for various clients. Evaluated Medical Device operations and
recommended corrective measures to ensure high
standard of quality and compliance with global pharmaceutical
regulatory requirements.
Consultpharm- Director, Scientific Affairs (2008 2009) Managed
both, the QA-QC services and the Regulatory Affairs services on
behalf of diverse clients
in Pharmaceuticals, Natural Health Products and Medical
Devices.
Markedly improved customer service and satisfaction,
prioritization of projects and requests, timemanagement and
planning, and smooth communication among team members. Initiated
the establishment of a new service on Drug Safety and
Pharmacovigilance and the
required infrastructure, expected to boost revenues by an
estimated 15 20% annually.
SPECTRUM Medical Market Consultants 2004 2005 Quality Services
Consultant
Developed the infrastructure and management of Quality Services.
Streamlined transitional administration from previous service
provider (including technical,
regulatory, document management and products under
development).
mailto:[email protected]:[email protected]
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Revised and maintained Technical/Quality Agreements with third
parties. Optimized Quality and Operations processes.
Recommended new cost management procedures to reduce local 3rd
party costs by 30-35% Devised a Contractor Selection Grid, to
evaluate potential suitors (numerical values) as per
objectives and criteria, thus ensuring unbiased and clarity of
selection. Improved contract efficiency and communication with
clients by preparing new Project Time
Reporting and reevaluation of expenditures.
SANDOZ (formerly SABEX Inc.) 2003 2004 Project Leader,
Regulatory Affairs
Prepared various product submissions to the US, Canada and the
European Community. Liaised with regulatory authorities to clarify
and inquire about pending issues related to products
under review or yet to be submitted.
PENDOPHARM Inc. (formerly Pangeo Pharma from Novopharm Qubec,
and before Rhne-Poulenc Rorer) 1985 2002
Manager of Regulatory Affairs and Product Development - Pangeo
Pharma (2 years)
Managed domestic and foreign Regulatory Affairs: DIN
applications and various submissions toTPD and FDA; Clinical
Supplies and Export (Canada, USA, UK, Australia and Japan).
Audited suppliers of API as well as reviewed and approved
validation protocols and reports. Identified needs and prepared
SOPs regarding Development Report and Technology Transfer.
Project Leader, Pharmaceutical Development Management and
Technical Services Coordinator -Novopharm Quebec(5 years)
Pharmaceutical Development projects: Developed generic versions
of innovators products forthe U.S. and/or the Canadian markets;
prepared Development Reports; SR&ED time up-keep forfiscal
benefits.
Team leader of PD projects: coordinated multidisciplinary
activities amongst various departments,different sites and with
subcontractors; patent review;
Optimized outside formulations to available equipment,
stewardship of process development andprocess improvement;
Reduced the set-up time by 50% by participation with an internal
task force (Packaging lines), in
project/product financial evaluation (COGs) and in the
department budget management. Managed Controlled Substances /
Narcotics (QPIC) and Alcohol Management (Power of Attorney);
was the official signing authority with domestic and foreign
government bodies; EstablishmentLicence.
Improving quality while decreasing costs: Devised a Productivity
Indicator (or PerformanceIndex) within a Statistical Process
Control framework and Continuous Improvement program.
QA Packaging Supervisor and senior Analyst Rhne-Poulenc
Rorer(now Sanofi-Aventis) (10 years)Managed Customer complaints,
Training and Clinical Supplies Projects.
Pressed on a change in the packaging process of a cream that
ensured a stable endproduct and extending its shelf life while
easing the in-process controls then required.
39% reduction in paperwork throughout the plant operations by
leading a team tooptimize the documents, thus alleviating the
workload by an equal measure.
Also worked as a QC Lab Supervisorat Pharmetics Ltd
EDUCATION & PROFESSIONAL DEVELOPMENT
McGi ll Executive Insti tute : Comple ted the ExecutiveTraining
ProgramUniversit de Montral: Pharmaceutical Manufacturing I &II
(Graduate level)
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B.Sc. in BiologyHautes tudes Commerciales (HEC): Studies towards
MBA
Additional professional development: Seminars, conferences and
courses dealing with TimeManagement, Doing More With Less / Cost
Containment, Coaching, and other topics such asCompliance,
Validation and FDA / PAI related issues.
Awards :Levels I & II Certificates of Achievement from
thePharmaceutical Sciences Group
