Quality Assurance 2Nd Shift

KAMRUL ISLAM

** **** ****, ******, **-***** 631-***-**** *************@*****.***

Self-motivated, articulate and goal orientated individual. Highly organized person able to handle multiple tasks simultaneously Reliable and dedicated individual with the ability to work quickly and effectively under pressure.

Education

Master’s in Geography of science, National University of Bangladesh.

(Evaluated by globe Evaluation Center. Manhattan, NY)

Professional Experience

Quality Assurance Associate, November 2018 to Present.Anneal Pharmaceuticals Inc.

Real-time testing of critical process parameters on Sharp Floor.

Perform Batch Record Review, Raw Material, Bulk and Finished Product Releases.

Collect data points during the production run to ensure process completion.

Ensuring that the final product/batch observes the company’s standards and is only released for distribution after strict standards are met.

Follow test methods and protocols for performing the quality assurance tests easily and efficiently.

Responsible for the development and implementation of inspection activities, the detection and resolution of problems, and the delivery of satisfactory outcomes.

Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

Issue production batch records and product labels to Operations based on manufacturing shop floor documentation.

Excellent ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.

Quality Assurance, - June 2009 to November 2018. InvaGen Pharmaceuticals, Hauppauge, NY

Work with supervisor in overseeing all activities and monitoring other QA operations and help as needed.

Review Manufacturing batch records.

Working in Blending, Granulation, Compression, Encapsulation, Coating.

Check for proper clean condition in all areas as per SOP&cGMP, rules.

Collect samples for lab from all departments including blend uniformity, validation sample according to protocol, potency assay, and K.F. Stability holding sample, complete analysis, etc.

Monitoring 2nd shift manufacturing all in process from QA side & reporting to QA Manager.

Quality Assurance, - June 2007 to November 2009. Country Life Pharmaceuticals, Hauppauge, NY

Work with supervisor in overseeing all activities and monitoring other QA operations and help as needed.

Review Manufacturing batch records.

Working in Blending, Granulation, Compression, Encapsulation, Coating.

Check for proper clean condition in all areas as per SOP&cGMP, rules.

Collect samples for lab from all departments including blend uniformity, validation sample according to protocol, potency assay, and K.F. Stability holding sample, complete analysis, etc.

Monitoring 2nd shift manufacturing all in process from QA side & reporting to QA Manager.

Quality Assurance- Advance Pharmaceutical Inc, Dec. 2004 to Apr 2007. Ronkonkoma, NY.

Conduct prestart up-inspection documentation check and release to run product in manufacturing and/or packaging.

Conduct in-process sampling and physical testing of product with required paperwork.

Complies with company policies and procedures and maintains regular work attendance. Performs other duties and assigned.

Executive officer, August 2002 to April 2004. GM Logistics Bangladesh.

Monitors productivity and motivates team members in distribution area.

Identifies issues affecting efficiencies and assists in developing solutions.

Ensure that all paperwork is properly documented.

Supervises counsels and team members on a regular basis. maintaining compliance with established policies and procedures.

Skills

Good manufacturing practice and safety training completed from InvaGen Pharmaceuticals Inc, Hauppauge, NY 11788

SAP experience

Computer skills and software such as Microsoft office tools.

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