Quality Assurance / Quality Control Profeetional

OBJECTIVE

Quality Control/ Quality Assurance Professional

HIGHLIGHTS OF QUALIFICATIONS

• Degree of Bachelor of Science (Special); Special Subject: Microbiology

• Over 10 years experience in Quality Control/Assurance and Regulatory Affaires

• Expertise in Microbial, Chemical and Instrumental Analysis

• Proficiency in documentation, training, establishment and auditing of Quality Systems such as cGMP, GLP and ISO 9000

• Approval by the Food and Drug Control Administration (FDCA) for Microbiological Testing

• Working knowledge of Windows 98/2000

• Internal Quality Auditor for ISO 9000:1994 and update to ISO 9000:2000 guideline.

SKILLS AND EXPERIENCE

Quality Management System Specialist

• Develop and delivered training to staff on Quality Systems such as ISO 9000:2000 and cGMP/WHO GMP and Indian GMP – FDA Schedule M.

• Audit the facility for ISO 9000:2000, GMP and GLP.

• Developed and Maintained procedures, forms and materials for auditing.

• Schedules Audit and conduct audit to monitor overall process performance and compliance with Quality Management Systems.

• Provided technical support in evaluating incident and non-conformances, root cause analysis and indentifying corrective and preventive actions.

• Provided training to new staff of QA/QC department on use of documents, facility and testing procedures.

• Developed and Maintained procedures, forms and materials for training.

• Maintained records for all type of QMS training for all level of employees.

• Schedules training session with employees in an effective and efficient manner. And provided training to improvements to existing quality management system training.

• Assessment of trainee by conducting quest and maintaining records or individual training quest.

• Developed Master Card for Pharmaceutical Bulk Drugs and Formulation preparation and Herbal Extract.

• Developed Batch Manufacturing Records for Pharmaceutical Bulk Drugs manufacturing and Formulation preparation such as tablet, capsule, dry & liquid syrup, sterile preparation.

• Prepared SOPs and formats for manufacturing, warehouse, quality control, and quality assurance and administration departments.

• Prepared documents for ISO 9000:2000 like Quality Manuel, Safety Manuel, Quality Object and Quality Policy.

• Participates in the on going developments of the QMS.

• Performed laboratory equipment calibration and validation as per GMP/GLP requirements.

Management and Coordination

• Completed Regulatory Affaires work activity with FDCA for obtaining permission for new product manufacturing and establish testing laboratory

• Managed the activities and operation of QC/QA and Contract Testing Facility as team leader and department head

• Developed strategic business plans for market Contract Testing Department

• Coordinated with employees and management for establishment and standardization of quality systems such as ISO 9000:2000 and GMP

Sandipkumar (Sandip) Patel 416-***-**** Page 2

Microbial Analysis

• Analyzed Antibiotics such as Gentamycin, Amikacin, Cefalxin and Vitamin B12 in finished product-formulation and raw material applying Microbial Assay test method based on pharmacopoeias

• Performed Microbial Limit Test to determine possible contamination of pathogens in raw materials and purified water. Carried out Sterility Testing to determine product standards for sterilization

• Examined Bio-burden to determine possible contamination of pathogens in Oral Grade formulation

• Evaluated manufacturing area for environment observation to determine possible contamination of microbes such as bacteria and fungi applying plate exposing method

• Established and standardized Microbial Testing Laboratory for the

Pharmaceutical Industries

Chemical and Instrument Analysis

• Estimated formulation and bulk drugs, applying chemical analysis methods such as assay, identification and limit test based on IP, BP and USP guidelines

• Operated GLC, IR, UV-Visible spectrophotometer, Colorimeter, Potentiometer, pH meter, Polarimeter, KF instrument, dissolution and disintrigation instruments

EMPLOYMENT HISTORY

Process Operator 2005 to till

Novo Pharm Ltd.

Stouffville, ON

Gujarat, India

Quality Control Microbiologist and ISO Coordinator 2004

Ansar Industries

Quality Assurance Executive 1998 – 2003

Mitshu Pharma Pvt. Ltd.

Department Head – Pharmaceutical Chemistry Research Officer 1995 – 1998

Jai Research Foundation

Quality Control Senior Microbiologist 1994 – 1995

Medinex Laboratories Pvt. Ltd

Shift Chemist – Microbiology 1992 – 1994

J. B. F. Industries Ltd., Pharma Division-I

Quality Control Microbiologist 1990 – 1992

Pharmaceutical and Chemical Industries

EDUCATION

Degree of Bachelor of Science (Special); Special Subject: Microbiology 1991

South Gujarat University, India

PROFESSIONAL DEVELOPMENT COURSES

Jai Research Foundation, India

Internal Quality Auditors Training Program 1998

Introduction and Update to Good Laboratory Practice Course 1995

Diploma in Quality Assurance from Kriger Research Center, Toronto –At present I am doing.

VOLUNTEER AND COMMUNITY WORK

Primary Teacher, I. P. Mission English Medium School, India, 2003 – 2004

Volunteer Staff, International Biopharmaceutical Association,

Toronto, Ontario, 2005

REFERENCES AVAILABLE UPON REQUEST

Contact this candidate