Chaher Soliman

4746, Prével
Pierrefonds, Qc H9K 1J4
H: 514-620-0344, C: 514-653-0344
solimanc@videotron.ca

OBJECTIVE
A senior management position in a pharmaceutical, biopharmaceutical or cosmetic firm where my ample
experience and proven track record will contribute to improved efficiency and increased productivity.

PROFILE
Fluently bilingual and highly qualified manager in plant and quality operations. Excels in streamlining
processes 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 and
compliance procedures and protocols. Champions projects to fruition with multidisciplinary teams. Thrives
in a fast-paced environment and consistently meets tight deadlines. Has an analytical and pragmatic mind
with 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 writing
and training, audit review; as well as familiarity with NDS (& S/NDS), ANDS and IND; ample knowledge
and experience in facility preparedness to Health Canada or FDA inspections (e.g. conducting internal
audits and mock inspections for plant readiness prior to FDA’s PAIs). Strength in complaints handling
and recall procedure, transport and storage conditions, and other operational principles.
PROFESSIONAL EXPERIENCE
NAMILOS Pharma Consulting 2005 to present
Founder & 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 SOP’s 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, time
management 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).
 • 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 Québec, and before Rhône-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 to
TPD 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 for
the U.S. and/or the Canadian markets; prepared Development Reports; SR&ED time up-keep for
fiscal 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 and
process improvement;
• Reduced the set-up time by 50% by participation with an internal task force (Packaging lines), in
project/product financial evaluation (COG’s) 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; Establishment
Licence.
• Improving quality while decreasing costs: Devised a “Productivity Indicator” (or “Performance
Index”) within a Statistical Process Control framework and Continuous Improvement program.

QA Packaging Supervisor and senior Analyst – Rhône-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 end
product 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 to
optimize the documents, thus alleviating the workload by an equal measure.

Also worked as a QC Lab Supervisor at Pharmetics Ltd

EDUCATION & PROFESSIONAL DEVELOPMENT

McGill Executive Institute: Completed the Executive

Training Program
Université de Montréal: Pharmaceutical Manufacturing I &
II (Graduate level)
 B.Sc. in Biology
Hautes Études Commerciales (HEC): Studies towards MBA
Additional professional development: Seminars, conferences and courses dealing with Time
Management, Doing More With Less / Cost Containment, Coaching, and other topics such as
Compliance, Validation and FDA / PAI related issues.
Awards : Levels I & II Certificates of Achievement from the
Pharmaceutical Sciences Group