Download Nader Moslemian B

Ravi Joshi B. Sc.
Summary of Experience:
Senior Manager with over 30 years experience in Product Development, Validation, Production, Quality Assurance and regulatory compliance within the
Pharmaceutical & Biotechnology Industry. Extensive in the conceptual design for sterile & non-sterile pharma and biotech manufacturing, filling &
packaging operations and the application of clean zone concepts. Innovative strategist skilled at assessing and implementing cost effective solutions with
effective training.
Experience Detail:
Torcan Chemical, Aurora, Ontario:
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Project Leader for Validation of Nitrogen System, reactors, Condensers, High Vacuum, Utility Vacuum, Dowtherm. Bailey System, Compressed
Air System and Utility Water for the newly constructed Pilot Laboratory. Supported Torcan management for a successful FDA inspection.
Cangene Corporation:
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Developed strategic plans to address the computer validation issues for various cGMP databases in the corporate technical & R&D operations to
lead into CFR 21 part 11 compliance.
Aventis, Toronto, Ontario:
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Provided consultation to the project manager for the design and validation of a pox vaccine facility to meet FDA, WHO & MCA requirements.
The scope included design, procurement, construction and validation of the complete facility including: HVAC, Purified Water/WFI, Compressed
Air, Pure Steam, Fermentation Suite, Purification and Formulation Suites.
Organon Canada Ltd., Toronto, Ontario:
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Developed the strategy and led the project for process validation and technology transfer for a solid dosage facility.
Dioptic Laboratories, Markham, Ontario:
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Led the project for upgrading the suppliers compliance performance, introduced validation for utilities, equipment, process and methods.
Canada Blood Services, Winnipeg, Manitoba:
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Conducted GMP audit of the new Winnipeg facilities, identified the gaps. Developed the master validation plan for the new facility. Managed the
Project for the validation execution of the Building Utilities, Laboratory Equipment, Processes, and Water System. Developed relocation strategy
for Winnipeg Blood Centre.
Intergen Biopharmaceutical, Toronto, Ontario:
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Managed the project for BSA equipment qualification that included, Distilled Water System, various types of Reactors, Mixers, pumps and filter
presses.
Alpha Therapeutics, Los Angles US:
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Conducted GMP audit of their two facilities and made recommendation for improvement to their validation program and CGMP compliance.
Boots Drug Company, Nottingham, UK:
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Project leader for the new introduction of semi-solid products. Streamlined manufacturing processing & material handling procedures. Streamlined
packaging operations and recommended and implemented the reduction of packaging materials.
Novartis Pharmaceutical Canada Inc., Whitby, Ontario:
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Assisted in the conceptual design for renovation and expansion of the central weighing, granulation, compression, encapsulating and liquid areas
to improve process flow, and implement clan zone concepts.
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Automated liquid manufacturing operations to produce 750,000 litres per year and recommended the filling and packaging line locations,
configurations and work flow for efficiencies and cGMP compliance.
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Established automated manufacturing, filling and packaging of a major US export of Rx. suspension product. (600 batches per year)
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Led Validation team for BPICS and MANCAN MRP/ERP systems implementation for the Canadian operations.
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Developed and validated roller compaction technology for powder products.
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Recommended the manufacturing sites and production portfolio allocation for North American operations for Novartis following the merger between
Sandoz and Ciba.
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Successfully obtained FDA accreditation for the Whitby manufacturing site. Prepared Master Validation Plan and Drug Master File.
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Formalised corporate internal and external audit programme, to standardise the inspections between different auditors.
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Successfully introduced Statistical Process Control in the plant and the laboratories to improve quality and reduced waste.
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Pioneered and implemented Validation and Change Control Management for the Canadian Operations.
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Co-authored guidelines for process, computer, equipment and cleaning validation for the North American Operations.
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Successfully introduced and managed site wide Matrix Organization for handling Plant Utilities & Equipment Qualifications, Computer
Validation, Process, Methods and Cleaning Validation by chairing the validation committee.
Aventis Pasteur Limited, Toronto, Ontario:
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Validation of facility and utility systems including layout, design, HVAC system, WFI system, DI water system, compressed air system and clean
steam system. Preparation and execution of installation qualification, operational qualification and performance qualification protocols.
Serologicals Corporation, Toronto:
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Developed a strategic business plan for BSA product Freeze- drying processing to out-source versus in-house processing. Evaluated current
technology and associated costs and compliance and validation requirement.
Allelix Biopharmaceuticals Inc., Toronto, Ontario:
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Reviewed all facility, utility systems, processes and production equipment for a biopharmaceutical facility. Plan corporate validation requirement
for the company. The scope included all facility systems, processes, equipment, validation program, GMP programs and resource estimate.
Bimeda-MTC Animal Health Inc., Cambridge, Ontario:
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Developed strategy for approach to cleaning validation program.
Education:
Affiliation:
B. Sc. Chemistry
ASQC, ISPE, PDA Board Member
PSG and Advisory Board Member of Food & Drug Faculty, Durham College
Board Member for University of Toronto – PDC BPCP Program