Customer Service Quality

CAREER PROFILE

< Over ten years of employment in the Pharmaceutical & Biotechnology

industries at both Quality and Production levels, with particular

expertise in aseptic processes

< A quick learner, strongly committed to enhancing the Quality-Productivity

vision of GMP and GLP run facilities

WORK EXPERIENCE

Sanofi Pasteur Limited, Toronto Canada (June 2006 - Oct 2009)

Professional, Quality Operations

. Performed in-house audit inspections to evaluate compliance with written

procedures and regulations

. Completed investigation reports in SAP for diverse types of non-

conformance events (Lab & Production OOS, coordinating product failure

investigations with regulatory bodies such as CBER, MHRA, NIBSC) by

investigating on site and inter-site department personnel

. Facilitated inter-departmental meetings focusing on streamlining document

management processes, such as reviewing, approving and consolidating

SOPs, CAPAs and Change Control Requests, converting SOPs to Standard Work

Instructions

. Performed equipment suitability assessments in preparation for the

purchase of new air-borne particulate counter (APC), microbial impaction

sampler (MIS) for compressed air bioburden monitoring, MGA Sterile

Connection Device, Clean room paper, within allocated project budgets.

. Developed URS, SOPs and IQOQ Protocols for the equipment, completed their

execution and report write-up also provided operator's training and

customer service to end users.

. Performed utility operational data analyses for the Annual Product Review

of Water system using JMP Statistical software tool; proposed

scientifically justified revision of operational parameters.

. Prepared schematic diagrams of water systems to facilitate better

understanding of the sampling plan by owner departments and QA monitors

. Participated in the Health & Safety assessment for the monitoring of

pharmaceutical gases

Kelly Scientific Services Toronto Canada (October 2005 - March 2006) QC

Microbiologist for Unilever-Best Foods and Maple Leaf Foods

. Performed various types of microbial testing on raw & finished product

samples

. Created laboratory protocols for a variety of lab equipment and optimized

microbial test procedures to minimize operator generated errors

Abbott Laboratories Ltd., Toronto, Canada (December 2003 - May 2004)

Production Supervisor/AQPIC, Sterile Production & Packaging.

With 21 permanent and 20 contract reporting staff, major Job duties

performed:

. Convened Production staff meetings to schedule employee activities,

direction & goal setting

. Improved efficiency of the operational process by introducing scheduled

cross-training for operators on production equipment

. Communicated effectively with all support departments (QA, QC, CAPA,

Engineering, and Warehouse) to meet scheduled tasks in line with Abbott's

vision.

Bimeda-MTC, Animal Health. Cambridge, Canada (October 2002 - March 2003)

QC Microbiologist

. Performed environmental monitoring of clean rooms, product staging areas

and Microbial & Endotoxin testing on raw materials and finished products

. Performed root cause analysis and made recommendations to eliminate

problems of contamination from batching tanks

Intelligene Expressions Inc., Edmonton, Canada (May 2000 - August 2002)

Senior Microbiologist Q.C.

. Revised procedures for EM & Water testing that resulted in 50% of time

and labour cost savings

. Assisted Engineering in performing various tasks that included thermal

distribution studies and validation of utilities/equipment (dry heat

ovens, steam sterilizers, RO water systems, magnehelic gauges,

centrifuges, etc.)

. Performed inhibition/enhancement endotoxin assays for neo-clinical

proteins, resolved the LAL reagent 'test standard' gelling problem.

Bristol Myers Squibb. Karachi, Pakistan (July 1996 - March 2000)

Production Supervisor, Small Volume Parenteral & Cream Ointment Division.

. Along with a team of 14 permanent and 6 Contract staff, met scheduled

tasks in line with company policies and procedures

. Improved sterile product yield by 12 % through effective control of

particles

. Reduced 4 hour cycle-time in vial sealing process by using the idle

machine facility.

. Assisted engineering department in the installation and performing

validation testing on newly installed autoclave, dry heat oven, and pure

steam generator (Steris)

. Participated in annual maintenance and performance check on production

equipment (Laminar flow hoods, component washers, Air flow patterns using

smoke tubes, process and system validation via Media fill trials, Batch

to Batch Cleaning validation of equipment used in different products.)

. Improved process flow for broth (media) fill by replacing bulk media

sterilization with filter sterilization.

EDUCATION

< University of Alberta, 2002. 'Research Techniques in Immunology &

Molecular Biology'

< University of Karachi 1995. Masters of Science in Microbiology

(equivalent to 4 year Bachelor of Science degree from a Canadian

university)

PERSONAL DEVELOPMENT

Attended over 60 developmental courses, few to mention are; Introduction to

Lean Six Sigma, HSE, Risk Assessment Approach, Root Cause Analysis for

CAPA, Introduction to Project Management, Pharmaceutical Water and Clean

room Verification, Assertiveness Skills, How to be an Effective Auditor,

Contamination Control and Clean room Behavior, NAIO Documentum, Trackwise

and SAP courses as required.

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