MD.REZAUL MOBARAK

***,******** **.

Selden,NY-***84

adx7x3@r.postjobfree.com

Contact: 347-***-****

Education:

Masters : December, 1984

Rajshahi University, Rajshahi,

Bangladesh.

BSS : December, 1983

Rajshahi University, Rajshahi,

Bangladesh.

Residency Status : Citizen in USA

Previous Work(January,2013 to May,2017): Quality Assurance Inspector

Country Life LLc, Hauppauge.NY

Present Work (June,2017 to Working ) : Quality Assurance Supervisor

MGI Pharmaceutical

140,Commerce Drive. Hauppauge.

NY 11788

Major responsibilities are:

To enforce good manufacturing practices, current good practices (CGMPs). The Dietary Supplement(DS) CGMP Rule in 21 CFR part 111,210,820 established & follow to ensure the quality of the DS and ensure all of this is package within the Specification, Issuing Includin

keeping,Sanitation,Cleaniness,EquipmentVerification&Procesvalidation. In every stage, maintaining SOPs, company standards and FDA. Approved vacation time of QA as per requirements. Check QA clockin and clockout & any irregularities need to fix. Examining tablets hardness, thickness, color & friability according to the specifications. Tablet, Capsule, Blending, Coating & Pharmacy room release. Tablets & capsules room start-up. Check Component, Label, Expiration date, Label Position. To inspect and then release processing in order to ensure the further quality of products (Within the specifications). Issuing & releasing batch record as preproduction requirements. Inspect the quality of products before, during and after processing. Sign & Check parameter setup and prepared Validation protocol for packaging line. Any Capping / Chipping or friability failed during start-up then identify the problem spoke to formulator and pull the previous batch record start deviation and took the approval from Quality director & reviewed re-work done by formulator and check the new target weight same procedure is applied if split/Dent capsules are findings & the formula will be reviewed for a possible formula change control. Tablet & Capsules Machine room Start-up. Issuing of Batch Record and Log in to Manufacturing as per requirement. Collect Retention & Stability Samples .Validation Qualifying batch by Checking Validation Protocol & Make Sure the Approved Parameter Limit also checking Gripper Speed, Spindle Speed, Cap Feeder,Supply Hopper,Rotary Feeder & Wiper, Nominal output, Carrier Belt Speed ect. Also By Checking NDC# & Revision # Pack insert & Medication guide.

Pharmacy, Blending, Tablet, Coating & Capsules room Log-in & Room release. Tablet, Coating & capsule room closed & calculate Quantity. Released D.I Water Plant Room for Tablet Coating. Log in the Finished Product Sample to the Q C & Micro Log book. Review Batch Record after Pharmacy & after Blending. Weight Variation of twenty Tablets/Capsules During Start-up by using Spred sheet. Calculation of Individual Weight,Hardness & Thickness by using Sotax Autometic machine During Start-up. Disintregation & Friability testing by following FG Analysis Tamplate During Start-up. Capsules Machine room Start-up by taking ten empty capsule Shells five times added divided by five calculation of Average weight of empty capsules Shell.Calculation of upper limit, lower limit & Target weight of fillup capsules.

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Enforcing the production of pure, safe and specific products. Submit daily Production Report & Comuinicuate with Blending and Production Supervisor to increase Production. Any Changes Write Deviation & Contact with R&D and check tablets/capsules count and bottle size and work in change control. Releasing bulk & Prepare Reconciliation paper & Calculate yield. Work as a Team Sprit.

Analyzing and releasing pharmacy and blending as detailed in SOPs.

Inquiring the blends in company storage area.

Checking the cleaning requirements of all mixture, blenders, and ingredients as per master formula (In the batch folder).

Periodic (1hr/2 hrs.) inspect and record the findings on the prescribed forms during the machine run.

Examining the tablets’ hardness, thickness and friability (according to the specifications).

Checking the changes of tooling in machine and sign the log sheets (according to the batch folder).

Releasing tot according to the batch requirements and inspect incoming tablets.

Checking the cleanliness of the machine and room area.

Ensuring the accuracy of the product and attaching to the final QA report in the batch folder.

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