Quality Assurance Control

ALPA AMIN

*** ********** ****, **** ****, ON L*A 6B5

Phone: 647-***-****

OBJECTIVE:

To effectively utilize my professional abilities to obtain a challenging

position in Pharmaceutical/food/chemical or medical equipment Industry.

SKILLS AND SUMMARY:

. OACETT (The Ontario Association of Certified Engineering Technicians

and Technologists) certified me "Technical Specialist" in Bioscience

. Approved by Food & Drugs Control Administration (Gandhi Nagar, India)

as a "Technical Person" in Microbiological testing, Pyrogen, Toxicity

and Sterility testing sections

. Canadian CO-OP work experience from Maple Leaf Foods and ILC Micro-Chem

Laboratory

. Hands on working experience as a Microbiologist/Quality Assurance

analyst from Pharmaceutical, Food and medical equipment industries.

. A dedicated and highly motivated team player and quick learner

. Knowledgeable of computer software: Microsoft Word, Excel

MICROBIOLOGY / QUALITY ASSURANCE EXPERIENCE

. Water sampling, testing and system validation as per USP, EP, BP, JP

pharmacopoeia

. Media preparation, growth promotion tests and Biological identifications

of contaminants

. Monitored daily Logs, Records and other documentation as required in SOPs

. USP/EP Antimicrobial Effectiveness Testing (AET).

. Microbial Limit Test, Total Aerobic Microbial Count, Total Yeasts and

Molds Count,

according to customer requirements, current compendia and

regulatory requirements

. Routinely performed Sterility, Toxicity, Bacterial Endotoxin Test and

Biological Assay

. Proficiently performed Environment monitoring, Sterilization method

validation

. ATCC Culture identification and population verifications

. Trained technicians in new techniques and oversee the progress as

required

. Documentation control, i.e. proper laboratory notation for data entry

to log books and report writing

. To recognize and report OOS results or deviations

. Specialized in Qualification and Calibration of instruments and

Physical-Chemical testing of finished products and raw materials

. In process QA control, Validation of Gamma radiation method

. Performed pre and post market stability (RT and accelerated), and

validation testing

. Prepared and revised analytical forms for laboratory analyses based on

approved test methods and monographs

. Maintained systems for control, issuance and reconciliation of analytical

forms

. Coordinated the preparation and issuance of forms and worksheets with

sample receipt to ensure documentation is available to the laboratory

in a timely manner

. Maintained custody of original copies of approved test methods and

monograph

EMPLOYMENT HISTORY:

Manager / Owner October 2009 to

September 2013

E-Z go Convenience, Fort Erie, ON

Packaging Operator 2007 to 2008

Patheon Inc. Mississauga, ON

Q.A Officer and Microbiologist 2006 to 2007

Universal Medicap Ltd., India - manufactures pharmaceutical rubber

closures in technical collaboration with Naniwa Rubber Co. Ltd. Japan; has

gamma radiation plant

Quality Control / Assurance Officer 2003 to 2006

Tonira Pharma Ltd., India - manufactures APIs & Intermediates (100% EOU)

Microbiologist 2000 to 2003

Mercury Laboratories Ltd., India - manufactures pharmaceutical products

Microbiologist 1997 to 2000

Elysium Pharmaceuticals Ltd, India - manufactures pharmaceutical products

(formulation of injection, liquid, ointment, tablets, etc.)

EDUCATION:

2009 Dufferin-Peel Catholic District School Board

Employability Skills with Cooperative Education Practicum

1995 M.B.Patel Science College, Anand, India

Medical Lab Technician Diploma

1994 Sardar Patel University, Anand, India

Bachelor of Science (Microbiology)

CERTIFICATION:

OACETT (The Ontario Association of Certified Engineering Technicians and

Technologists) certified as "Technical Specialist" (Bioscience)

Approved by food & drugs control administration (Gandhinagar, Iindia) as a

"Technical Person" in following fields:

1) Microbiological testing section (since Oct-1999)

2) Pyrogen & toxicity testing section (since April-2001)

3) Sterility testing section (since September-2003)

Contact this candidate