Project Manager Management

IMTIAZ

ESS: **** DELFI ROAD MISSISSAUGA L*L *S*, ONTARIO, CANADA

E: 001-289-***-****

ab290v@r.postjobfree.com

OBJECTIVE

To seek a Validation/Project Engineer position in the Pharmaceutical organization that allows me to utilize my technical

knowledge and practical experience to obtain the goals of the organization.

SUMMARY O F QUALIFICATIONS

• Over 10+ years of Pharmaceutical operations, Validation/qualification, Project Management, and HS&E.

• Highly skilled and trained from Hoffman La-Roche, Switzerland on HS&E, cGMP, Validation/Qualification, CSV,

CAPA, Annual product review and Project Management.

• Proven record of flexibility and adaptability to various roles & responsibilities.

• Works well independently as well as collaboratively in a team setting.

• Knowledge and ability to fulfill international standards like OSHA, US & European Pharmacopoeia, FDA,

ASHRE and ASME.

• Competent user of Ms Office products; able to learn and apply new software quickly.

P ROFESSIONAL EXPERIENCE

Packaging Assistant at Ciba Vision Inc. Canada from Mar 2013- to date

Packaging pharmaceutical products - Inspection of packaged products for any defects - Ensure line cleanliness practices,

procedures, SOPS and GMP's - Maintain a clean, organized and safe work environment

Project Manager at Otsuka Pharmaceutical Pakistan from Jun 2012- Dec 2012

Performed GMP Renovation of old plant sections by following the cGMP requirements for area/room, zoning/HVAC, and

material /personnel flows. Check and ensure the design layout for correctness.

Production Technician at Apotex Pharmaceutical Inc. Canada from Jan 2012- Mar 2012

Carried-out activities related to manufacturing processes (extrusion/marmorisation, drying and sieving) of Osmeparazole

as per BMR and work instructions and required SOP’s. Ensure room cleanliness practices, procedures, SOPS and

GMP's. Maintain a clean, organized and safe work environment.

Packaging Assistant at Ciba Vision Inc. Canada from Jul 2011- Jan 2012

Packaging pharmaceutical products - Inspection of packaged products for any defects - Ensure line cleanliness practices,

procedures, SOPS and GMP's - Maintain a clean, organized and safe work environment.

Manager Validation & Projects at Hoffmann-La Roche Pakistan from Jan 2000- May 2011

Primary duties included:

-Responsible for executing equipment, utilities, process, CSV and cleaning validation activities and technical projects for

Roche. Technical duties include writing and executing validation documents, reviewing and analyzing data, adhering to

domestic and international GMP regulations, incorporating continuous improvements into validation activities and policies,

and participating in regulatory inspections.

-Support tech transfer activities as required and provide technical assessments on change controls, deviations, and

investigations.

-Conduct business meetings with vendors/contractors and to stay current with professional development. 1/3

Responsibilities included:

Write, execute, summarize validation activities in the following areas: Varies, 30-80%

-Facilities-Equipment-Shipping / Cold Chain-Process-Cleaning-Steaming / Autoclave-Computerized Systems(CSV)

-Plant Automation

-Validation Maintenance

-Validation document control and archival program

Develop and assess the following Quality System elements for Validation:

-Quality Risk Management program

-CAPAs-Change Controls -Deviations-GMP Investigations

Participate and contribute in design, development, validation strategy, and routine GMP activities:

-Provide technical input to strategy/philosophy for validation activities

-Represent validation during tech transfer activities as required.

-Represent validation during site GMP activities and participate on

cross-functional teams

On-going

Identify opportunities for continuous improvements, participate in the deployment of best practices, pro-actively update

validation programs to reflect current regulations and trends.

Varies, 10-20%

-Participate in partner audits and regulatory agency inspections for Validation.

-Author and review sections of regulatory filings and annual product quality reviews.

-Train other staff on validation equipment and protocols.

Equipment/Systems validated:

-HVAC for class 100/1000/10,000/100,000 and compressing rooms.

-WFI-Clean nitrogen/compressed air-Chilled water-Clean steam-DI water-cold rooms, cool area, incubators,

freezers, refrigerators, compounding tanks-autoclave-incubators-sterilizer by using Kaye validator.

-Packaging equipment-Autoclaves-Solid dosage equipment/facilities- Semi solid and liquid equipment/facilities

-Computerized system validation (CSV) of business software BPCS and criteria for CSV for Plant

systems/machines on GxP classifications. -Process validation

Engineering Project related activities performed:

• Facilities layout modification, FAT testing, construction, commissioning, equipment installation and validation

-verification of filling equipment construction (FAT), equipment installation and validation - supervision of outside

contractors and bidding procedures.

• Developed the project time line graphics of each project execution stages.

• Develop comparative studies for supplier/vendor selection as per corporate guidelines.

• Good interactions with different contractors and assess their strength and weakness.

• Plan and assessed all the project activities phases for most efficient and effective utilization of available

resources.

• Checked design drawings for dimensional correctness.

• Rendered layout and elevation drawings for construction projects.

• Provided on site checking of “as built” drawings.

• Successfully managed the execution stages of following projects, right from user requirements to project

handover;

HVAC system DI water system Fire alarm systems

Cool area in warehouse Cold room Sampling booth

Air Handling Units Stability Chambers Laminar Flow Cabinet

2/3

Production Supervisor (on job rotation) at Hoffmann-La Roche Pakistan from Jan 2006- Dec 2006

Manufacturing Section:

• Supervise the daily running of production process of all manufacturing operations.

• Ensure that the line of production is running smoothly and whether the teams and individual workers are meeting

their production targets

• Organizing and planning staff shift rotas and tasks.

• Reporting the breakdowns of machinery or plant to maintenance technicians.

• Team motivation & Stock control.

• Monitoring quality control.

• Generating management reports on performance.

Packaging Section:

• Supervise and coordinate activities of workers engaged in packaging products and materials for storage or

shipment.

• Study production order to ascertain type and quantity of product, containers to be used, and other packaging

requirements.

• Inspect products prior to packaging and returns rejected products to production departments.

• Observe packaging operations and inspects products/materials to verify conformance to specifications.

• Start, adjust, and repair packaging machinery, or notifies maintenance department.

Site S&E Officer (additional responsibility) at Hoffmann-La Roche Pakistan from Jan 2007- Dec 2008

Safety:

• Carried out risk analysis of potential hazards, safety audits, inspections, fire and evacuation drill.

• Established and updated safety SOP’s, emergency plans and Safety Handbook.

• Prepared data and completed annual safety report and other reports required by CSE Basel.

• Conducted local emergency management exercise at site.

• Trained temporary and new employees on day one safety training.

• Maintained and updated the record of MSDS.

Industrial Hygiene and Health:

• Examined workplaces against hazardous dust, solvent fumes and noise as per CSE Basel Directive.

• Observed adequate illumination, ventilation and other ergonomics considerations.

• Ensured use & purchase of safety equipments and reporting any deviation of laid down safety procedures.

• Monitored annual medical checkup of all employees as per CSE Basel Directive.

Environmental Protection:

• Conducted and reviewed EIA of facility designs & operations to identify and address potential environment

impacts.

• Developed procedures to monitor and control the potential impact of operations on the environment.

• Ensured compliance with national environmental quality standards.

• Reviewed monitoring of emissions to air and effluent discharges.

• Monitored, suggested and implemented ways of reducing, recycling and improving methods of waste disposal.

EDUCATION

• Bachelor Degree in Mechanical Engineering(University of Toronto equivalent) from 1993-1997

• Master Degree in Environmental Engineering(University of Toronto equivalent) from 2000-2003

• PMP certification (in process) and willing to acquire any required certification.

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