Manufacturing Training

Curriculum Vitae

Zahidur Rahman

Contact Address

C/O Khursedur Rahman (Asst. Headmaster)

Dhanmondi High School, Free School Street

Hatirpool, Dhaka-1205, Bangladesh

Contact No: +880**********

E-mail: *********@*****.***,

*********@*****.***

Academic

Qualification________________________________________________

B. Pharm (Honours):

2004 (Held in 2005)

Khulna University, Khulna-9208, Bangladesh

First class

Obtained marks 67.41%

Higher Secondary Certificate (H.S.C)

1999

Dhaka City College, Dhaka-1205, Bangladesh

Dhaka Board

First Division

Obtained marks 73 %

Secondary School Certificate (S.S.C):

1997

Dhanmondi High School, Dhaka-1205, Bangladesh

Dhaka Board

First Division

Obtained marks 76.7 %

Job

Profile________________________________________________

Joined as Executive, Production on 01 March’ 2006 in Square Pharmaceuticals Ltd. Dhaka unit, Bangladesh, which is the leader in pharmaceutical arena in Bangladesh and also approved by UK MHRA.

Current Position:

As Sr. Executive, Production since January, 2011 in Square Pharmaceuticals Ltd., Dhaka Unit, Bangladesh.

Manufacturing Experience:

I have worked on solid dosage forms (tablets, capsules), sterile ophthalmics, small and large volume parenterals, insulin, pre-filled syringe, blood products (albumin), lyophilized products and MDI.

Solid dosage forms:

I have 1 year experience in supervision of manufacturing of solid dosage forms (Tablet, Capsule). I have worked with different groups of drugs which include synthetic and semi synthetic antibiotics, NSAIDS, anesthetics, antihistamines, vitamins, antivirals, anthalmentics and cardiac drugs.

I also have the experience to face UK MHRA, KSA and other international regulatory inspection and prepare the unit for the success.

Small volume and Large volume parenterals and Ophthalmics:

I have worked from the very ground level of this unit and qualified all process equipments, developed the documentation system as per cGMP regulation and prepared this unit for commercial production. I am supervising the aseptic manufacturing of small and large volume parenteral and ophthalmic products of Blow/Fill/Seal (BFS) technology and also the ophthalmic products of conventional 03 piece technology. I am also working as one of the key member of US FDA inspection readiness team for this unit.

Insulin, Pre-filled syringe, Lyophilized and MDI:

I have also worked in this unit to qualify all process equipments, develop documentation system as per cGMP regulation and prepared this unit for commercial production. I am working with recombinant human insulin products in vial and cartridge form, prefilled syringe and lyophilized products. In addition I am working with HFA based MDI products.

I have the experience to commission and qualify of the following facilities and equipments-

- HVAC system of sterile manufacturing area

- Tablet compression machine

- Fluid bed dryer

- Blending machine

- Capsule filling machine

- Blow/Fill/Seal machine for small volume parenterals and ophthalmics

- LVP bag filling machine

- 03 piece ophthalmic filling machine

- Autoclave machine

- Vial washing machine

- Vial sterilization and de-pyrogenation tunnel machine

- Liquid vial filling machine

- Solution preparation vessel

- CIP (Clean In Place) and SIP (Sterilization In Place) system

- MDI filling machine

- Prefilled syringe filling machine

- Lyophilizer

- Blister machine

- Ventilated and Non-ventilated pass through box

- Laminar Air flow unit

- Cold chamber

I am also working as an active team member to implement SAP system in the manufacturing units I am responsible for.

Key Responsibilities:

• Supervising the all stages of manufacturing and packaging activities with GMP compliance.

• Participation in commissioning of production equipments and machineries.

• Preparing PQ protocols of process equipments and to participate in IQ, OQ and PQ activities.

• Preparing Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR).

• Preparing Process Validation Protocol and to participate in validation activities.

• Perform media fill validation as per Validation Master Plan.

• Ensuring the proper cleanliness of process equipments.

• Ensuring the environment for aseptic manufacturing operation.

• Assessing the training need of the production staffs and provide training to them for maintaining the aseptic environment, behavior and aseptic manufacturing operation.

• Preparation and routine revision of SOP’s and to provide training to all staffs accordingly.

• Monitoring and maintaining records of In-process Check (IPC).

• Checking the batch documents and ensuring quick release to QA after batch completion.

• Meeting the production target according to the sales forecast.

• Ensuring the line clearance for manufacturing and packaging area.

• Assessment of production resources to maintain smooth manufacturing operation.

• Preparing monthly production report based on production plan and achievement

• Recruitment and appraisal of production staffs.

Personal Details_____________________________________________

Father’s Name: Khursedur Rahman

Mother‘s Name: Fatema Khatoon

Date of Birth: 3rd June, 1982

Place of Birth: Dhaka.

Sex: Male

Marital status: Married

Religion: Islam

Nationality: Bangladeshi

Permanent Address:

Village-Baira

P.O. -Baira

P.S. - Muradnagar

District-Comilla

Bangladesh.

Others_____________________________________________________

PharmacyRregistration: Registered pharmacist of Bangladesh Pharmacy Council (BPC)

Phramaceutical Training:

• Training on “Process and System Validation” and “Sterile Process Validation and Sterilization” conducted by APC (Asia Pacific Consultants Pvt. Ltd., Australia)

• Training on ‘Cleaning Validation and Cross Contamination Control’ – conducted by Darek Smith (consultant and Ex. TGA auditor)

• Training on ‘Validation- FDA Perspective’ and ‘Validation – Basic Conceppts and Strategies’ - conducted by Suggy Chrai (Chrai Associates, USA)

• Training on ‘CFR 211- current Good Manufacturing Practice’, ‘Aseptic Processing – Current Good Manufacturing Practice’ and ‘Quality Systems Approach to Pharmaceutical GMP Regulations’ - conducted by Suggy Chrai (Chrai Associates, USA)

• Training on ‘Validation Master Plan’ - conducted by Suggy Chrai (Chrai Associates, USA)

• Training on ‘Good Documentation Practice’ - conducted by Suggy Chrai (Chrai Associates, USA)

• Training on ‘Change Control System’ - conducted by Suggy Chrai (Chrai Associates, USA)

Language efficiency:

Bengali : Native

English: Overall 6.5 in IELTS academic module (2009)

(Reading-6.5, Speaking-6.5, Listening-7.5, writing-6.0)

Computer literacy:

• Microsoft Office Package : MS word, MS Excel, MS Power Point, MS Access, MS Visio

• Programming language: C – programming

• Graphics software: Auto CAD, Adobe Photoshop

• Operating system: Windows 98, 2000, XP, Vista

• Keen user of internet.

• Good knowledge in hardware and software

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