PERSONAL PROFILE

ASMA AIJAZ
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Details: Address: Contact:
Date of birth: 10th Dec 1981 D-1 Broadway apartment, +923452059919
Nationality: Pakistani Bahadurabad, Karachi, [email protected]
Pakistan.

COMPUTER SKILLS

• Microsoft office (word, excel, power point),
• Web designing

EMPLOYMENT HISTORY

Linz (Group of Bosch Industries) Pharmaceutical (Pvt) Ltd.

Incharge Microbiology Section Quality Control Department.
(July 2016- till date)

• Shelf life study of culture media used in the microbiology lab after undergoing the process of sterilization.
• Implementation of environmental monitoring program/ sop as per the latest requirement s of the ISO.
• Review of production SOPs related to sterile area.
• Gap analysis in the presently existing method/system.
• Certification/ recertification of personnel getting access in the sterile area.
• Review and verification of raw data and results.
• Responsibility for developing, supervising and training of the concerned QC, QA and production staff.
• Review the pharmacopoeia to determine if Analytical Procedures need to be updated.
• Review and checked laboratory note books and records to ensure accuracy and completeness.
• Review all analytical data, entry registers, log books, graphs, documents released stickers etc, to ensure accuracy and completeness.
• Monitoring and validation of water system.
• Monitoring of controlled sterile and non sterile production environment.
• Plan, schedule and organize validation projects for new and existing area.
• Interface extensively with the QC/QA, Production and maintenance department to identify projects and problems requiring validation support.
• Validation of cleaning procedures of production related equipment
• Develop and implement all necessary SOP for validation of plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), and requalification of of critical system, utilities and production processes.
• Design IQ/OQ/PQ and validation campaigns, develop, prepare and write protocol for IQ/OQ/PQ.
• Perform the equipment qualification IQ/OQ/PQ.
• Review and analyze complex analytical and physical data generated from validation activities.
• Plan and perform thermal mapping of equipments.
• Check and ensure the calibration of plant’s equipments.

Linz (Group of Bosch Industries) Pharmaceutical (Pvt) Ltd.
QC Senior Executive (July 2013- June 2016).
• Bio assay of antibiotics.
• Investigation of OOS in special concern with sterility and Bet failure.
• Identification of organism by API kits.
• Sterility test.
• Microbial Limit Test.
• Bacterial Endotoxin Test (Gel Clot method)
• Involvement in media runs.
• Validation / revalidation of newly and previously used disinfectants.
• Cleaning validation.
• Validation of dry heat sterilization.
• Validation of moist heat sterilization.
• Trend analysis (environmental monitoring).
• DOP/HEPA filter integrity test.
• Air pattern test.
• Airflow velocity.
• Pressure differential.
• Handling and maintenance of ATCC cultures.
• Sop preparation and updating.
• Documentation

Linz (Group of Bosch Industries) Pharmaceutical (Pvt) Ltd.
QC Executive (July 2010- June 2013)
• Viable monitoring of sterile and non sterile area by both active and passive method.
• Non viable monitoring of sterile and non sterile area.
• Growth Promotion Test.
• Microbiological assay.
• Validation of steam sterilizer (Biological Indicators, Bowie Dick test).
• Validation of dry heat sterilizer (Endotoxin Challenge Test).
• LAL test of sterile finished products, W.F.I and in process samples.
• Sterility test of finished products, W.F. I and Raw materials.
• MLT of raw material packaging material, and finished products.
• Monitoring of compressed air (sterile nitrogen/ air).
• Monitoring of clean steam.
• Efficacy of disinfectants.
• Handling and maintenance of ATCC cultures.
• Identification of micro organism by API strips.
• Documentation

Bosch (Plant I) Pharmaceutical (Pvt) Ltd.
QC Executive (May 2009-June 2010)
• Viable monitoring of sterile and non sterile area by both active and passive method.
• Sterility test.
• Microbial Limit Test.
• Bacterial Endotoxin Test (chromogenic technique)
• Water testing.
• Bio assay.
• Neutralization of vial containing cephalosporin.
• Gram staining.
• Handling and maintenance of ATCC cultures.
• Identification of micro organism by API strips.
• Maintain entry and released record of finished products.
• Maintaining record of media preparation.
• Maintain inventory and reconciliation.
• Review of batch documents.
• Prevention of cross contamination.
• Documentation

Tabros Pharmaceutical (Pvt) Ltd.
QC Officer (Sep 2007-May 2009)
• Viable monitoring of sterile and non sterile area by both active and passive method.
• Non viable monitoring of sterile and non sterile area.
• Growth Promotion Test.
• Microbiological assay.
• Microbial Limit Test of suspensions, syrups, creams, ointments and capsules.
• Bacterial Endotoxin Test (chromogenic technique)
• Sampling of water
• Testing of city water. D.I water, distilled water , double distilled water and W.F.I.
• Identification and isolation of micro-organisms.
• Gram staining.
• Maintain entry and released record of finished products.
• Maintaining record of media preparation.
• Maintain inventory and reconciliation.
• Sampling of active and inactive raw materials.
• Microbial and chemical testing of raw material.
• FTIR
• pH
• Conductivity.
• In process.
• Checking of temperature and RH sterile area.
• Preparation and sterilization of biological media.
• Disposal of waste media.
• Supervised batch rejection.
• Inspection of sterile, non sterile, ware house, dispensing area.
• Handling and maintenance of ATCC cultures.
• Disintegration Of in process or semi finished products.
• Hardness testing.
• Investigation of non sterile finished products failure.
• Documentation.

EDUCATION

M.Phil Microbiology (thesis writing in progress) 2016-till date
Federal Urdu University of Arts Science and Technology, Karachi.

Master of Science (Microbiology) 2006
University of Karachi, Karachi, Pakistan.

Bachelors of Science ( Microbiology, Biochemistry, Chemistry) 2003
University of Karachi, Karachi, Pakistan.

Higher Secondary School Certificate 1999
Board of intermediate, Karachi, Pakistan.

Secondary School Certificate 1997
Secondary Board , Karachi, Pakistan.

Instrumentation:

• Biosafety and Laminar flow cabinets.
• Millipore filtration unit
• FTIR.
• Spectrophotometer.
• Centrifuge machine.
• Ultra centrifuge machine.
• PCR machine.
• spin
• pH meter.
• Vortex mixer.
• Mini spin machine.
• Conductivity meter.
• Balances.
• Autoclave.
• Dry heat sterilizer.
• Incubators.
• Cool incubators.
• Talgent Mini Incubator.
• Microscope.

Certification:

• Uses of isolaters, biosafety and laminar flow cabinets.
• Solution to manage Antimicrobial resistance threat.
• Certificate of Excellent Performance from Zia-ul-Haq Shaheed Foundation.
• Web desigining certificate from BTWA.
• Advanced Typing certificate from Rangoon Wala Community Centre.
• Quwaid-ud-Tajweed Quran Certificate from Maddarsa-tul-Binat Zaheer-ul-Islam.
Research work/Thesis:

Screening and Characterization of Silver Nanoparticles Synthesized by Indigenously isolated Enterococcus spp.

Training:

• Liquid Particlate counter SVPs, LVPs.
• Air particulate counter ApexZ50.
• Air sampler Active Count100.

Awards and honors:

• Certificate of appreciation for the effort made in investigation of Biobured of Fosfomycin Calcium.

REFRENCES:
To be provided on request.