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Quality Assurance Manager

Location:
Toronto, ON, Canada
Posted:
January 12, 2020

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Resume:

JOHN BOSCO BIZIMANA

*** ***** ****** ***,

Ottawa, ON, K1K 3Y2

Tel: 587-***-****

Email: ada95u@r.postjobfree.com

SUMMARY OF QUALIFICATIONS

Over 20 years of experience in Biological Sciences.

Trained in Microbiology, Environmental Biotechnology, public health, Animal Health and Agriculture.

Highly experienced in pollution control & waste management, quality assurance, regulatory affairs, good manufacturing practices, occupational health and safety and manufacturing in aseptic environments.

Designed and installed state-of-the-art Wastewater Treatment Plants in developing countries.

Inventor in Aerobic Wastewater Treatment (patent pending).

Highly experienced in odour control from wastewater treatment plants.

Established an in-house certification program in quality assurance department designed to ensure personnel, product and environmental protection.

Strong analytical and problem solving abilities.

Adaptability and flexibility.

Oral and written communication skills.

Excellent motivator and leader.

Computer skills.

Bilingual (English & French).

RELEVANT EXPERIENCE

Regulatory Affairs

Prepared regulatory submissions.

Responded to questions from Regulatory Authorities (National Bureau of Standards, National Institute of Health, Centre for Disease Control, Environmental Protection Agency and Distributors.

Inspected Manufacturing Establishments for Regulatory Compliance.

Reviewed Summary Documents and Standard Operating Procedures (SOPs).

Maintained a Regulatory Library.

Quality Assurance

Investigated contamination problems and took the appropriate corrective action.

Designed, implemented and maintained the routine environmental monitoring programs for controlled environments (Aseptic filling areas & sterility testing areas).

Reviewed testing results for compliance with cGMP and recommended corrective action when limits were exceeded.

Evaluated and maintained environmental validation status for aseptic processing areas.

Developed and wrote validation SOPs and Protocols.

Assisted in the technical review of proposed plans and specifications for new or renovated controlled environments and containment areas.

Trained and recommended new techniques and procedures to address cleanroom issues.

Tested and Certified HVAC HEPA filters, Biological Containment Cabinets, Laminar flow hoods, Chemical fume hoods and La Calhene Isolators. Research & Development

Optimized and Scaled-up processes in preparation for production of clinical trial lots.

Developed purification protocols for viral and bacterial antigens.

Designed and performed a variety of laboratory experiments.

Analyzed data and prepared reports.

Maintained calibration, certification and validation documentation. Manufacturing

Prepared and reviewed batch production records.

Formulated a variety of bacterial vaccines.

Prepared equipment for sterile filtration.

Acted as a quality assurance liaison to ensure cGMP compliance.

Trained personnel in aseptic techniques.

Troubleshot cleanroom and HVAC problems.

Performed environmental monitoring in controlled environment. Facilities Management

Inspected manufacturing facilities.

Acted as a Quality Assurance & Regulatory Affairs Liaison.

Ensured that the company was environmentally compliant.

Recommended suitable laboratory equipment to purchase.

Prepared air system descriptions.

Liaised with contractors and equipment manufacturers.

Prepared floor plans.

Reviewed air-balancing reports.

Agriculture

Herbicide Application.

Soil sampling, testing & analysis.

Dairy Production.

Hog Operation.

Veterinary services.

Winery.

Waste Management

Instrumental in the Design and Installation of packaged mechanical wastewater treatment plants in Rwanda.

Prepared an operation & management manual for the Nyanza Landfill Site in Rwanda.

Carried out Wastewater Treatment Studies – Analysis of sites (using GIS) & assessment of priorities for the City of Kigali.

Developed & Installed odour control systems for on-site wastewater treatment systems in Rwanda.

Analyzed test data from wastewater treatment systems to ensure that all effluent parameters are compliant with the certificate of approval/Environmental Standards.

Assisted in the planning, design and installation of anaerobic digesters to process sewage sludge and produce methane gas and organic fertilizer for agricultural applications.

Involved in the design and construction of composts to handle biodegradable organic waste materials to produce stable, sanitary, humus-like product that is used for soil improvement.

Developed Packaged Aerobic Wastewater Treatment System using Special Biological Media (Patent Pending).

Sewage Sludge Treatment and composting to produce liquid & solid Organic Fertilizer suitable for agricultural applications. EMPLOYMENT HISTORY

Enviroclean Technologies 2002 - Present

(Executive Chairman)

World Bank /City of Kigali 2000- 2002

(Waste Management Consultant)

Pasteur Merieux Connaught 1989 - 1998

Regulatory Specialist 1996 - 1998

Environmental Specialist 1989 - 1996

T.G Brights Wine 1989

(Microbiologist)

CIBA – GEIGY 1986

(Research Associate)

Larson’s Hog Operation 1985

(Manager)

NORAD/ILRAD 1984

(Research Associate)

EDUCATION & TRAINING

Pollution Control Accreditation Harvard University, USA 1990

(Environmental Engineering) (School of public health) B.Sc. in Agriculture University of Saskatchewan 1989

(Applied Microbiology) CANADA

Diploma in Animal health Egerton University, KENYA 1983

(Veterinary Science)

Professional Development Courses:

Environmental Pollution Control & Waste Management.

Occupational health & safety.

Certification of Laboratory/Medical Equipment.

Current Good Manufacturing Practices.

Good Laboratory Practices.

Cleanroom Design & Management.

Food Safety & Quality Assurance.

CPR (cardio-pulmonary resuscitation).

Computers.

Team-Building.

Time Management.

Project Management.

Conflict Resolution.

References

Available upon request



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