1. Md. Altaf Hossain
Head of QC & Compliance, Quality Assurance, ACI Limited, Narayanganj
Ph: +88-01766691287; E.mail: hossainaltaf@yahoo.com
SUMMARY OF QUALIFICATIONS: ___________________________________________
Total Job experience: More than 15 years (Pharmaceutical)
 1 year & 8 months experience (continuing) as Head of QC & Compliance in ACI Limited
 Three (3) years & 8 months experience as Deputy Manager, Quality Control (Track-II),
Beximco Pharmaceuticals Limited.
 Two (2) years experience as Sr. Asst. Manager, Quality Control (Track-II), Beximco
Pharmaceuticals Limited.
 Six (6) years experience as Executive, Quality Control at Novartis (Bangladesh) Limited.
 Two (2) years experience as Officer, Quality Control at Novartis (Bangladesh) Limited.
 Six Months Experience as a Chemist in Tetrahedron Inc. (Arsenic Mitigation Project under
BAMWSP).
WORK HISTORY_____________________________________________________________
 Head of QC & Compliance, ACI Limited From Sept 2014 – Present
Key Responsibilities:
• Responsible for release of solid, liquid, cream, ophthalmic, ointment, injectable, MDI
& animal health products produced at ACI Limited, Narayangonj Plant & Other toll
manufacturing sites.
• Responsible for local contract manufacturing products of SERVIER produced at ACI
Pharma Factory.
• Supervise Quality Control, Microbiology, Quality Compliance, Validation, Export
Registration & Source Validation team.
• Ensure environmental protection at the plant in line with regulatory requirement.
• Plan and execute QC & Compliance activities for on time disposition of materials and
products as per production and Marketing needs.
• Responsible for approving GMP documents of QC, Compliance and Production.
• Responsible for proper execution of Deviation management, Change Control
management, Market complaint, OOS/OOE etc.
• Responsible for compliance and in-process control activities.
• Responsible for validation activities (process validation, equipment/utility/facility
validation, Source Validation etc.) and stability studies.
• Responsible for implementation of ISO 9001 & 14001, GMP (ICH, PIC/S, WHO etc.)
guidelines, GLP in the respective areas to ensure regulatory compliance.
• Responsible for handling internal & external audit including third party supplier of RM
& PM.
• Responsible for development of competent new & alternative sources.
• Act as key player to meet new product launch targeted by Sales and Marketing.
• Responsible for co-ordination of product transfer from one site to others.
• Guide and train members of the production, engineering, Commercial and QA team
towards excellent work performance in line with regulatory requirement.
Page 1 of 7

2. Md. Altaf Hossain
Head of QC & Compliance, Quality Assurance, ACI Limited, Narayanganj
Ph: +88-01766691287; E.mail: hossainaltaf@yahoo.com
 Deputy Manager, Quality Control (BPL, Track-II) From Jan 2011 – Aug 2014
Key Responsibilities:
• Supervise & lead the QC team to achieve the target.
• Implement and maintain Good Laboratory Practices in QC laboratory to meet the
regulatory requirements of the local as well as highly regulated markets.
• Resource planning for QC, budgeting and developing facilities to keep QC always
ready to support the planned production.
• Prepare, review & update the QC documents (SOPs, STPs, GTPs etc) in line with
updated Pharmacopoeia / Guidelines.
• Execute proper & timely sampling, testing & release of Raw Materials & Packaging
Materials.
• Execute the testing of In-process & Finished product, process validation & cleaning
validation samples.
• Conduct stability study of OSD, MDI & DPI products and prepare stability report to
support shelf life.
• Supervise to carry out Analytical Method Validation and Analytical Method transfer
activities as per ICH & Pharmacopoeial requirements.
• Liaise with different departments of BPL & suppliers (Local & International) for
smooth operation QC activities.
• Liaise with International Regulatory Affairs Department for product registration in
different countries through preparation of regulatory Dossiers.
• Train the QC staff to develop their skill & retain talents.
 Sr. Asst. Manager, Quality Control (BPL, Track-II) From Jan 2009 – Dec 2010
Key Responsibilities:
• Supervise & lead the QC team to achieve the target.
• Implement and maintain Good Laboratory Practices in QC laboratory to meet the
regulatory requirements of the local as well as highly regulated markets.
• Prepare, review & update the QC documents (SOPs, STPs, GTPs etc) in line with
updated Pharmacopoeia / Guidelines.
• Sampling, Testing & Release of Raw Materials & Packaging Materials.
• Testing of In-process & Finished product, process validation & cleaning validation
samples.
• Conduct stability study of OSD & MDI products and prepare stability report to support
shelf life.
• Carry out Analytical Method Validation activities.
• Liaise with purchase department, planning department & suppliers (Local &
International).
• Liaise with International Regulatory Affairs Department for product registration in
different countries through preparation of regulatory Dossiers.
Page 2 of 7

3. Md. Altaf Hossain
Head of QC & Compliance, Quality Assurance, ACI Limited, Narayanganj
Ph: +88-01766691287; E.mail: hossainaltaf@yahoo.com
• Train the QC staff to develop their skill & retain talents.
 Executive, Quality Control, Novartis (BD) Ltd. From Jan 2003 – Dec 2008
Responsibilities:
• Planning, organize & execute the quality control tests for the incoming Raw materials,
Packaging materials and Finished products of Pharma, Sandoz (Local & Export),
Animal Health, Ophthalmic and Third Parties.
• Provide necessary support to QC Manager for release of Raw materials, Packaging
materials and Finished products in timely manner for the market.
• Prepare and update all GMP documents related to Quality Control (e.g. SOP, GM) and
give proper training to the QC personnel.
• Prepare & update all testing instructions & purchase specifications as per registration
requirements of different countries and the requirements of EP, BP & USP.
• Provide necessary support (i.e., document) to different RCC’s and Registration Centre
to prepare & update dossier for different molecules.
• Guide and train members of the QC team toward excellent performance.
• Provide necessary support to all QC personnel for smooth operation & to act as a team
to face challenges under stressed condition.
• Ensure readiness and perfect technical status of the QC Equipments,
Reference/working standards and reagents.
 Officer, Quality Control, Novartis (BD) Ltd. Jan 2001 – Dec 2002
Responsibilities:
• Perform sampling and analysis of Raw & Packaging materials as per Novartis policy and
guideline.
• Perform analysis of the FDFs with full documentation.
• Perform analysis of the sample from new source and develop alternative supplier.
• Prepare and update analytical protocol of all Raw and Packaging materials.
• Perform analysis of the complaint sample and handle complaint.
• Perform qualification of the analytical equipments.
 Chemist (Tetrahedron Inc.) June 2000 – Dec 2000
Responsibilities:
• Determination of concentration of Arsenic (by Atomic Absorption Spectrophotometer)
and other heavy metals (by UV method) in ground water of different districts (different
villages) of Bangladesh.
• Collect ground water from the mitigation units installed at different villages of
Bangladesh and determine the concentration of Arsenic & other heavy metals.
Page 3 of 7

4. Md. Altaf Hossain
Head of QC & Compliance, Quality Assurance, ACI Limited, Narayanganj
Ph: +88-01766691287; E.mail: hossainaltaf@yahoo.com
• Evaluate the performance of the mitigation units and prepare report.
• Give knowledge to the people of the arsenic affected areas and make them aware to
avoid drinking arsenic contaminated water.
• Monitor the activities of the other employees and report to management.
 Audit Faced in Beximco Pharmaceuticals Limited
 TFDA GMP Audit – Held in 2013
 TGA GMP Audit – Held in 2012
 ANVISA GMP Audit - Held in 2012
 NDA (Uganda) GMP Audit- Held in 2012
 NAFDAC (Nigeria) GMP Audit - Held in 2012
 AGES (EU) GMP Audit – Held in 2012
 AGES (EU) GMP Audit – Held in 2010
 TGA GMP Audit – Held in 2010
 ANVISA GMP Audit - Held in 2009
 Audit Faced in Novartis (Bangladesh) Limited
 EU GMP Audit - Held in 2001 (by German Health Authority)
 EU GMP Audit - Held in 2003 (by German Health Authority)
 EU GMP Audit - Held in 2005 (by German Health Authority)
 EU GMP Audit - Held in 2007 (by Austria Health Authority)
 ANVISA Audit – Held in 2007 (by ANVISA & WHO expert for Brazil)
 MCC Audit – Held in 2007 (by Department of Health, South Africa)
 HSE Audit – Held in 2008
 GMP Audit by Taiwan Health Authority in 2008
 GQA Audit – Held in 2005
 Research Activity
 One year research experience in Metal-Amino Acid systems by controlled potential
Techniques in the Department of Chemistry, University of Dhaka.
 GMP Training obtained
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5. Md. Altaf Hossain
Head of QC & Compliance, Quality Assurance, ACI Limited, Narayanganj
Ph: +88-01766691287; E.mail: hossainaltaf@yahoo.com
 All GMP related trainings at Beximco Pharmaceuticals Limited
 All GMP related trainings at Novartis (Bangladesh) Limited.
 3 days Training on “Maintenance of Working Environment & Safety in Industries” by
Ministry of Labor, Peoples Republic of Bangladesh.
 Training on Quality Compliance & Change Control Management by QPRS.
 Day long training on “Training of the Trainers” at Beximco Pharmaceuticals Limited.
 Professional Training obtained
 Training on Management Development Program provided by PINNACLE (3 days).
 Training on HPLC Method Development & Trouble shooting at Shimadzu
Corporation Pte Ltd., Singapore (2 days).
 Situational Leadership Training by Novartis (Bangladesh) Limited at Rajendrapur (6
Days).
 COMPASS (Management Development Skill) Training by Novartis (Bangladesh)
Limited at BRAC CDM, Rajendrapur (7 days).
 SAP Software Training on Quality Control (release) activities at Novartis (Bangladesh)
Limited.
 More than 15 On-line training of Novartis on Business ethics, Code of Conduct etc.
 2 days Computer training on Excel and Networking at BRAC-CDM
 Training on Metrohm Potentiometric Titrators at Textile Engneering University at Dhaka
by Metrohm, India Ltd.
 Training on Perkin-Elmer GC, HPLC (Shimadzu, Merck-Hitachi, Agilent), Shimadzu IR
Prestige, Malvern Mastersizer (Particle size analyzer).
 Foreign Travel
 Singapore (to attend training on HPLC Method Development & Trouble shooting).
 Computer Literacy
 MS Word, Excel, Powerpoint.
 Special Software: Malvern-Mastersizer S; IR Prestige solution; Shimadzu HPLC – Class
VP, Prominence Solution ; Agilent 1100 series (HPLC) – Chemstation; Dionex HPLC –
Chromleon; Perkin-Elmer GC–HS Autosampler; UV-Vis 302; FT NIR - NITCAL, TOC.
Page 5 of 7

6. Md. Altaf Hossain
Head of QC & Compliance, Quality Assurance, ACI Limited, Narayanganj
Ph: +88-01766691287; E.mail: hossainaltaf@yahoo.com
 Expert in
 Malvern Particle size Analyzer, FT-IR (Shimadzu), FT-IR (Unicam), UV
Spectrophotometer (Halios), FT – NIR, HPLC Shimadzu, HPLC Agilent, HPLC Dionex,
Perkin- Elmer GC with HeadSpace Auto sampler, Alpine AirJet Particle size analyzer,
Melting Point Apparatus (Auto), Kjeldal systems, TOC Analyzer, Karl-Fisher
Autotitrator, Potentiometric Titrator, Autoclave, Dissolution Apparatus (Satorius),
Dissolution Apparatus (Electrolab), Viscometer, pH Meter, Conductometer, polarimeter etc.
 Personal Information
 Education
M.Sc. (Thesis):
Major Physical & Inorganic Chemistry
Year of Passing 2000
Institution University of Dhaka
Class obtained 1st
Class
B.Sc. (Hons)
Major Chemistry
Year of Passing 1999
Institution University of Dhaka
Class obtained 2nd
Class
H.S.C.
Major Science
Year of Passing 1993
Institution Carmichael College, Rongpur
Division obtained 1st
division
S.S.C.
Major Science
Year of Passing 1991
Institution Lalmanirhat Govt. High School
Division obtained 1st
division
 Personal details
Father’s Name Md. Ismail Hossain
Mother’s Name Mrs. Rahima Begum
Present Address House # 322/3, F # 5/3, Shenpara, Parbata, Mirpur -10,
Dhaka 1216.
Permanent Address Vill: Jogatber, P/O: Jogatber, P/S: Patgram, Dist: Lalmonirhat
Date of Birth 06 May 1975
Page 6 of 7

7. Md. Altaf Hossain
Head of QC & Compliance, Quality Assurance, ACI Limited, Narayanganj
Ph: +88-01766691287; E.mail: hossainaltaf@yahoo.com
Religion Islam
Nationality Bangladeshi (by birth)
Marital status Married
Wife Niloy Monjuri Miti (M.Sc. in Psycology & Post graduation
certificate on Psychotherapy, BSMMU).
Profession: Psychologist & Counselor.
Work place: HARMONY (a mental health support center),
Banani, Dhaka.
Children Ayan Anon (son)
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