A.F.M Tarek is seeking a challenging position in quality assurance where he can utilize his skills and experience. He has over 7 years of experience in quality assurance roles at pharmaceutical companies, ensuring compliance with cGMP guidelines and preparing for regulatory audits. His resume outlines his educational background in pharmaceutical science, work history managing quality systems, and track record of contributions and achievements across multiple employers.

1. Career Objective
Specialty Area
RESUME
OF
A.F.M TAREK
Contact Address:
Cellular: 01740773055
E-mail: tarek_mbju@yahoo.com
To build up my career in a challenging and rewarding position at a winning organization where
creativity, sincerity, skill, performance and honesty are the criteria for one’s appraisal and
recognition.
Ensuring quality medicine at every steps of manufacturing and packaging as per cGMP
guidelines and face different regulatory audit.
Personal Information
Full Name A.F.M. Tarek
Nick Name Nayon
Father’s Name Late. A.F.M. Abdullah
Mother’s Name Kohinur Sultana
Date of Birth April 19, 1986
Present Address 103/A, Mohammadia Housing Society,
Mohammadpur Dhaka.
Permanent Address 40/21, Shahid Abdur Razzak Sarak
Court Para, Kushtia.
Blood Group A+
(ve)
Marital Status Married
Religion Islam
Nationality Bangladeshi by Birth
National ID 2617272885499
Contact Number 01740773055
E-mail tarek_mbju@yahoo.com
Educational Records

2. Career Highlight
Examination
Name of the
Institution
University /
Board
Passing
Year
Result
M.S in
Pharmaceutical
Science
Department of
Pharmacy
Jahangirnagar
University
2009
(Held in
2010)
3.29
(4th
Position)
B.Pharm
(Hons.)
Department of
Pharmacy
Jahangirnagar
University
2008
(Held in
2009)
3.58
(6th
Position)
H.S.C. Kushtia Govt. College Jessore 2004 5.00
S.S.C Kushtia Zilla School Jessore 2002 4.88
Performed a Thesis on “Analytical Assay Method Development and Validation of Atorvastatin
Calcium” as a team member of method validation team in Beximco Pharmaceuticals Ltd.
(Track-II) on 2010 to fulfill the prerequisite of M.S in Pharmaceutical Science Program and
the thesis paper was published on Stamford Journal of Pharmaceutical Science.
22 December 2015 – Till today: Executive, Quality Assurance Department, Novartis
Bangladesh Ltd.
Major Responsibilities:
• Coordinate and preparation of Annual Product Quality Review report.
• Update QA master document like Quality Manual, Site master file, VMP, SOP, GM
and Protocol.
• Batch document review and release for packaging & sale through SAP
• Quality incidence, Customer & Deport complaint Investigation & report preparation.
• PSA handling for export country
• Control & management of CR
• CAPA tracking and management from Self Inspection, Deviation, Customer
Complain, APQR etc.
• Conduct Qualification (IQ, OQ, PQ) task for machine and report preparation.
• Document issue, review, control, distribution and archive.
• Training conduction.
• Supervising Dispensing & In process check in manufacturing and packaging area.
• Ensure first time quality and follow up to update cGMP requirements & inspection
readiness.
Achievement/Contribution:
• Proposed 5S system to implement in the factory premises
• Proposed for Nitrogen purging system in Powder of Suspension line to reduce market
complaint
• Proposed for reviewing of reconciliation calculation in the BMR
• Successfully faced EU & Novartis HSE audit in 2016.
18 April 2011 – 14 December 2015: Executive, Quality Assurance Department, Square
Pharmaceuticals Ltd. Dhaka, Bangladesh.

3. Major Responsibilities:
• As a validation team member perform different types of Validation and Qualification
tasks (protocol preparation, review, execution & report preparation) like Media Fill
validation, HVAC Qualification, Water and pure steam system validation, Autoclave
validation, Hold time study, Process and cleaning validation of different dosage form
• Update QA master document like Quality Manual, Site master file, VMP, SOP and
Protocol.
• CAPA tracking and management from Self Inspection, QIR, Deviation, Customer
Complain, APQR etc
• Handling of Deviation
• Coordinate and preparation of Annual Product Quality Review report.
• Quality incidence, Customer & Deport complaint Investigation & report preparation.
• Perform risk analysis and ensure risk reduction of pharmaceutical process, utility and
equipment
• Artwork development of Packaging material.
• Conduct Qualification (IQ, OQ, PQ) task for machine/system/utility etc and report
preparation.
• Coordinate training of Cephalosporin’s Plant.
• Perform vendor audit and self inspection as audit team member and report
preparation
• Perform vendor qualification.
• Handling of return goods, rejection and redressing
• Dossier preparation according to regulatory requirement.
• Batch release for packaging and sale through SAP
• Handling of change control document and change implementation.
• Responsible for document issue, review, control, distribution and archive.
• Supervising Dispensing & In process check in manufacturing and packaging area.
• Ensure first time quality and follow up to update cGMP requirements & inspection
readiness.
Achievement/Contribution:
• Reduction of retention sample quantity (tablet &capsule) from 102/100 pieces to
54/60 pieces and this approach save almost 700000 BDT per year from Square
Cephalosporin’s unit.
• Implement auto stoppering process rather than manual stoppering by piece of metal
(for 26 ml bottle) to minimize quality risk (crushing of glass particle from bottle
opening to the filled powder) in Cephalosporin PFS filling room.
• Took initiative with other concern department for quick consumption (within 1 year
rather than 10 years) of idle lid foil (unprinted alu lid foil, silver color 131 mm) in
Lebac 250 capsule before being lost its quality.
• Give an idea to convert the Rotor mill (idle) to knife hammer mill by shaft changing
and ensure highest utilization of Man and Machine. This concept also reduce sucrose
crushing time in cephalosporin plant
• Introduce the idea for seperate BMR of excipient drying in Tray dryer and planned
validation program accordingly.
• Identified the necessity for introduction of NFD (no feed detector) in IMA blister
machine (Lay out no.83 DS007 05 031) for automatically empty blister identification
in cephalosporin plant.

4. • Took initiative for solving weight variation problem (by replacing the vibration unit
or some other adjustment in PFS filling machine of cephalosporin plant) and dust
minimization (by introduction of gasket under the funnel in PFS filling machine).
• Proposed to introduce autocartoning facility for export order of injection packing to
save man and machine hour.
• Prepared more informative and precise IPC specification according to SAP
• Proposed for cage trolley for proper segregation of dispensed material which is
already implemented.
• Successfully faced Tanzania Food and Drugs Authority Audit, TGA audit, Sudan
Food and Drug Administration audit.
07 January 2010 – 17 April 2011: Officer, Quality Control Department, Beximco
Pharmaceuticals Ltd. Dhaka, Bangladesh.
Major Responsibilities:
• Analysis of Raw material Finished Product and Packaging Material.
• Operation of sophisticated lad equipments like HPLC, GC
• Preparation and review of specification and test methods.
• Validation of test procedure as a validation team member.
• Preparation and review of SOP/EOP/ECP.
• Sampling of Raw material.
• Organizing retention sample of Raw material.
• Organizing destruction of excess raw samples.
• Control of Laboratory inventory (CRS, WS, HPLC column, Reagents & glassware).
• Ensuring GLP at every step of laboratory activity.
• Proper documentation and retention of raw data and facing internal and external audit.
Achievement/Contribution:
• Reduced testing (5 batch interval) of Paracetamol BP was initiated for two limit tests
(sulphate test & chloride test) as Paracetamol was in house material and the trend
analysis found satisfactory. This initiative saved a lot of reagents & man hour.
• Reduced the UV spectroscopy identification procedure from Paracetamol BP method
as there were another two identification process (IR spectroscopy & HPLC). This
approach makes the testing procedure cost effective.
• Analytical assay method of ‘Atorvastatin Calcium’ was developed and validated as a
team member of method validation to establish an assay method for this INN product.
• Generate a study for mobile phase storage for 72 hours for some fast moving product
and thus reduced their analytical time.
• Introduced cleaning validation concept for dispensing utensils.
• Developed myself as a successful operator of sophisticated QC instrument like GC,
HPLC, Potentiometer, IR, UV, Particle counter, TOC etc.
• Successfully faced TGA audit and Drug Administration audit.

5. Special Feathers
Training and workshop attended
• Successfully completed in plant training at Incepta Pharmaceuticals Ltd.
(Period: 15th
December ’08 to 4th
January’09).
• GMP Training- Organized by Square Pharmaceuticals Ltd. Conducted by Rob
Walker, GMP Consultant in 2011.
• How to face FDA Auditor - Organized by SQUARE Pharmaceuticals Ltd conducted
by Mr. Shamim Aziz, USFDA expert in Canada in 2013.
• Aseptic Manufacturing Process and quality Risk Management – Organized by
SQUARE Pharmaceuticals Ltd conducted by Rob Walker, GMP Consultant in 2013.
Computer Proficiency
Operating System Windows xp
Word Processing Microsoft Word
Spread Sheet Analysis Microsoft Excel
Presentation Microsoft Power point
Internet Browsing, Data search
• Have leadership quality, honest and sincere to work
• Can take prompt action/decision with proper justification.
• High eagerness to learn about new technology/item/process
• Dynamic, Communicative and self-motivated.
• Take initiative to resolve the problems with alternative solutions.
• Hard working and capable of working under pressure.
• Able to create supportive environment within peers.
• Having positive attitude and treated problems as an opportunity to improvement.
Professional Affiliation
Registered pharmacist from Bangladesh Pharmacy Council (Registration No. A-3804)
Reference
Aseya Akhter Khanam
AGM, QA ………………………
Square Pharmaceuticals Ltd. A.F.M Tarek
Cell: 01730700624

6. Special Feathers
Training and workshop attended
• Successfully completed in plant training at Incepta Pharmaceuticals Ltd.
(Period: 15th
December ’08 to 4th
January’09).
• GMP Training- Organized by Square Pharmaceuticals Ltd. Conducted by Rob
Walker, GMP Consultant in 2011.
• How to face FDA Auditor - Organized by SQUARE Pharmaceuticals Ltd conducted
by Mr. Shamim Aziz, USFDA expert in Canada in 2013.
• Aseptic Manufacturing Process and quality Risk Management – Organized by
SQUARE Pharmaceuticals Ltd conducted by Rob Walker, GMP Consultant in 2013.
Computer Proficiency
Operating System Windows xp
Word Processing Microsoft Word
Spread Sheet Analysis Microsoft Excel
Presentation Microsoft Power point
Internet Browsing, Data search
• Have leadership quality, honest and sincere to work
• Can take prompt action/decision with proper justification.
• High eagerness to learn about new technology/item/process
• Dynamic, Communicative and self-motivated.
• Take initiative to resolve the problems with alternative solutions.
• Hard working and capable of working under pressure.
• Able to create supportive environment within peers.
• Having positive attitude and treated problems as an opportunity to improvement.
Professional Affiliation
Registered pharmacist from Bangladesh Pharmacy Council (Registration No. A-3804)
Reference
Aseya Akhter Khanam
AGM, QA ………………………
Square Pharmaceuticals Ltd. A.F.M Tarek
Cell: 01730700624