RESUME:

SARBJIT SINGH GHUMAN **-SENIOR CRESCENT CAMBRIDGE (ONTARIO).

E-MAIL: adb46h@r.postjobfree.com

PHONE: 519-***-****

EXPRESSION OF INTEREST: To secure an Entry Level Quality Assurance/Regulatory Affairs associate’s role in the Food, Pharmaceutical or Agricultural industry where my vocational skills and education can be best utilized to broaden my skills further and to meet company goals.

2017– 2018: Academy of Applied Pharmaceutical Sciences (AAPS), Toronto

Postgraduate Diploma: Regulatory Affairs and Quality Assurance in Pharmaceuticals, Food and Natural Health Products, Medical Marijuana, Cosmetics and Medical Devices.

1991-1996: Punjab Agricultural University, India

B.V. Sc&AH – 5 Yrs (Veterinary Sciences & Animal husbandry)

Canadian Equivalency from: I.C.A.S GUELPH (CANADA).

SUMMARY OF SKILLS (AAPS TORONTO):

Vocationally/hands-on trained: SOPs, CoA, CAPA, change control, deviations, and audit reports.

Canadian Food and Drug Regulations and Act, Cannabis Regulations and Act

GPP (Good Production Practices), GMPs, CFIA regulations, SQF principles, OHSA, CSA standards, sanitation and pest control in food production/storage/distribution facilities.

Excellent knowledge and understanding of Canadian regulations/guidelines concerning development, manufacturing and distribution of pharmaceutical, veterinary health products and biological products.

Attained knowledge of eCTD/CTD and related electronic submission processes as per ICH recommendations.

Proficient with MS Windows: Word, Excel, PowerPoint; Corel Office and Lotus Notes.

Skilled to inspect/regulate packaging and labelling of the drug/food products.

HACCP, BRC certified

Certified to achieve total quality management (TQM) in food companies.

Certified to conduct auditing at food/pharmaceutical facilities.

Regulatory submissions for Health Canada / FDA for NHPs, OTC and medicinal products (NDA, NDS, ANDA, ANDS, SNDS etc.).

Excellent knowledge of regulatory processes in the USA and Canada.

Regulation of medical marijuana and medical devices.

Working knowledge of the USP (United States Pharmacopeia).

Completed 3 QC courses in Pharmaceutical Lab.

Skilled in Assessment of existing compliance management systems.

Skilled to perform audit personnel, infrastructure, process/performance management and regulatory compliance.

Learned to comply with all applicable job procedures as outlined in SOP manual.

Strong knowledge of methodologies of regulatory affairs in the food manufacturing sector.

HANDS ON EXPERIENCE: IN-CLASS PROJECTS;

Prepared and reviewed documents required for quality systems and developed (SOPs, CoA’s,).

Investigated deviations, out of specifications and took decisions to initiate CAPAs and change control procedures.

Prepared auditing documentation (agendas, response letters, checklists and audit reports)

Prepared submissions for NHPs, OTC, DIN, medicinal products and medical devices through utilization of eCTD and followed ICH guidelines.

Completed food safety enhancement projects through hazard assessment, hazard evaluation, hazard determination and hazard management in HACCP environment.

Utilized FSEP manual for HACCP projects, Sanitation and pest-control projects.

Completed in-class projects regarding raw material receiving as per specifications and conducted sampling of raw materials, in process and finished products.

Gained and applied skills to use and calibrate autoclaves, temperature controls, water systems, bacterial filters, calibrated pH meters, analytical balances, metal detectors, X-ray devices, calculators, scales, gauges, callipers, micrometers, rulers and ovens etc.

Knowledge of SAP functions such as, hold/release, inspection lots, usage decisions, and quality management checks.

Gained and applied knowledge of Statistical Process Control (SPC) and analysed data in forecasting and taking decisions to increase productivity using:

Pareto charts, Control charts, Histograms, Time series (run) charts, basic lean and six-sigma skills in process improvement.

Mathematical tools, measuring instruments, statistics and project management skills.

Participated in continuous improvement workshops.

Demonstrated excellent communication, problem-solving and sound judgment skills.

Exhibited organization skills, shown attention to detail at work and in-class projects.

Trained and supervised sub-ordinate employees, proof-reading/document reviewing skills.

Worked well in the team work or individually with minimum supervision.

CANADIAN WORK HISTORY:

Erie Meat Products, Listowel: 2019 - presently

Working as production team member on RTE lines.

Ensured food quality and safety through application of GMPs, HACCP, routine Sanitation and Documentation as per company policy.

Learned the process of sample collection for QA purposes.

Visually inspected food products and packaging at various stages of processing and sanitized food lines frequently.

Helped operators in performing changeovers.

Achieved excellence in team-work as well as in individual tasks with minimum supervision.

SECURITY CONCEPTS INC: Licensed Security Guard 2016-2019

GUELPH TOOL INC: Auto-parts assembler/inspector 2011 - 2013

GRAND RIVER FOODS CAMBRIDGE Sanitation worker 2010

Accomplished safety and quality of food products through adoption of effective cleaning/sanitation and pest control procedures on food contact surfaces and food production/storage facilities.

Learned and applied skills to safely handle chemicals, MSDS, GMPs.

Learned to identify CCPs, completed work related documentation and recorded spills and wastes.

Learned and applied skills like, disassembly and reassembled oven parts after sanitation.

WORK EXPERIENCE INDIA:

Veterinary Officer/Dairy Products Inspector/Meat inspector in Animal Husbandry Department of Punjab Government, (INDIA). 1998-2005

Treated small and large animals in rural conditions.

Lead Vaccination and disease control teams in normal and flood affected areas.

Ensured food safety by conducting milk inspections against physical contamination, chemical contamination, adulteration and biological contamination with microorganisms.

Conducted regulatory inspections (e.g. on-farm inspections of dairy facilities, equipment and operations, physical inspections of transport vehicles and storage depots).

Prepared inspection and violation reports.

Investigated situations of non-compliance.

Enforced corrective action plans for instances of non-compliance.

Provided expert advice and assistance to producers and transporters to ensure safe, high-quality raw milk.

Performed various tests, took samples and analyzed data to help producers.

Identified areas for improvement to raw milk quality production, collection, storage, transportation, processing and distribution.

Developed and delivered a variety of educational tools / materials to producers and industry representatives.

Conducted pre-slaughter, post mortem examinations.

Performed Hygienic handling and processing of meat/carcasses including chilling, cutting, deboning and harvesting of products for further processing, packaging, labelling and shipping of meat/meat product in compliance with standards.

Inspected local meat shops to enforce food safety regulations.

Monitored, evaluated and ensured that the premises, processes and operation are in compliance with standards as well as production meet minimum regulatory requirements.

Monitored and implemented food safety programs.

Achieved quality Assurance through documentation, auditing and training staff members.

Experienced in humane handling/transportation and welfare of animals.

Experience of application of policies, procedures and regulations to achieve food safety and quality.

THANKS

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