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Quality Assurance Process

Location:
Matawan, NJ
Posted:
December 31, 2023

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Resume:

Maharshikumar R. Bhatt

ad2ct4@r.postjobfree.com

+1-732-***-****

Professional Summary

Complete 8 years of experience in Oil and Gas Refinery, Petrochemical, as well as 2 years in Pharmaceutical Quality Assurance.

Service & Maintenance

Operations and Maintenance

Reporting and Documents

Audit Operations

Team Management

Quality Assurance work

Adapt a handing day by day quality related activities in coordination with internal and external departments for ensuring smooth Quality and Operation.

Experience in maintain and updating data and update departmental records and databases.

Standard operating Procedure (SOP) for in process Quality Assurance check points and procedure during manufacturing of drug product in pharmaceutical.

Create all batch records entry in the system.

To ensure process validation programme being followed.

In-process quality assurance responsibilities of in-process during manufacturing drug.

Willing to continuously work on construction/maintenance sites and travel worldwide.

Environmental, Health and Safety mind-set and compliance

Excellent communication skills in the English language.

Willing to travel, work any shift, weekends and holidays to meet customer requirements.

Legally authorized to work in United States as a permanent resident (Green Card Holder)

Technical Skills

Followed standard operating procedures, manuals and work instruction for quality assurance related operation.

To calibrate all tablet weight machine daily.

To verify that the daily balance varification of scales and balance in the production area is performed every day.

To insure that instrument are calibrated prior to use.

To ensure that the right material has been provided for the packaging before line clearance.

Planning and scheduling of preventive & shutdown maintenance of the plant machineries like Heat exchangers, columns, pressure vessels, reactors, flare stack.

To verify and approve the room and equipment based on clean and dirty hold time requirement in effects.

Assists in and plan to organized batch records.

Ensure that work carried out in compliance HSE policies for a safe working environments and avoiding accidents.

Execution of job as per schedule and approved SOP.

Assist Manager Maintenance in Brake down and Preventive Maintenance in the plant.

Coordinates activities with plant operation departments.

To approve the rerelease of equipments after manufactruring department cleaning of PM..

Review and approve the preventive maintenance or work orders if necessary.

To ensure that designated area clean before that area use for dispensing granulation, milling, blending, or compression.

To ensure that when materials of one lot are being transported from processing area to another, there should not be any cross contamination generated in other processing areas.

To approve all dispensing room.

Give all major clearance for the manufacturing room prior to start the new batch.

To collect the samples of the Final product from every new batch and record it in the databases.

To approve the tooling prior to use before major cleaning.

Do material check and metal check before starting any batch Give start up by doing required test like weight, individual tablet or capsule weight, thickness, hardness to ensure the quality standard.

Document the reading every one hour during manufacturing.

Maintaining the log books for the batch records.

Data entry of the finished product in to the system

Responsibilities of in process during packaging to approve minor and major cleaning for all packaging rooms.

Approve the packaging labels for lot number and expiry date prior to give start up batch for clear visual verification of the Lot number and correct expiry date.

To collect required stability samples during the packaging and submit the QC along with the test request forms.

Organizational Experience

Currently working as a Quality Assurance Associate 2 in Raritan Pharmaceutical, New jersey .

From December 2021 to July 2022 worked as a Quality Assurance Tech 1 in Guardian Drug Company, New jersey .

From July 2021 to November 2021 worked as a Mechanical Shop floor Supervisor in Galileo Technologies, New jersey.

From November 2020 to June 2021 worked as a Chemical Plant Maintenance Supervisor in Firmenich, Newark New jersey.

From march 2020 to november 2020 working as a Drill Room Machining Supervisor at R&D Altanova, New Jersey .

From September 2018 to February 2019 worked in shutdown at BAHWAN ENGINEERING COMPANY, MUSCAT OMAN as a Mechanical Engineer.

From April 2018 to May 2018 worked in shutdown at HALDIA PETROCHEMICAL LTD, HALDIA as a Mechanical Engineer

From February 2018 to March 2018 worked in shutdown at ADVANCED PETROCHEM, JUBAIL SAUDI ARABIA as a Static Mechanical Project Supervisor in Reactor Agitator Installation job.

From May 2017 to July 2017 worked in shutdown at RELIANCE INDUSTRIES LIMITED (LLDP), NAGOTHANE as Maintenance Engineer

From February2017 to April 2017 worked in shutdown at RELIANCE INDUSTRIES LIMITED (CRACKER), HAZIRA SURAT as MECHANICAL MINOR PROJECT CELL ENGINEER in Cracker column Tray Installation job.

From October 2016 to December 2016 to December 2016 worked in shutdown at RELIANCE INDUSTRIES LIMITED (GAS CRACKER), DAHEJ as a Maintenance Engineer for Piping and Flare Stag, Flare Tip and Structure Commissioning Job.

From March 2016 to September 2016 worked in RELIANCE INDUSTRIES LIMITED, JAMNAGAR (DTA HYDROGEN) as a J3 Project Engineer

From February 2015 to March 2016 worked as a “Mechanical Commissioning Engineer” in SIMGAS, THE NATHERLANDS. (KENYA, EAST AFRICA)

Professional experience in manufacturing Industry as “PROJECT Engineer” with Zion Engineering Works, Manjusar, Vadodara from August 2012 to January 2015.

Company Profile

Raritan Pharmaceutical is New jersey based OTC Pharmaceutical company.

Guardian Drug Company is Dayton New Jersey based Pharmaceutical Company.

Galileo is Argentina based Oil and Gas Equipment manufacturing company.

Firmenich is New jersey based Fragrance manufacturing Chemical Planat.

R&D Alatanova is New Jersey based Testing Panels manufacturing company for I.T companies like Intel, QUALCOMM, and Plexus etc.

SIMGAS is The Netherlands based company, working on maintenance solution on oil & gas and biogas industries in India, Kenya Tanzania and European countries.

BAHWAN ENGINEERING COMPANY, Muscat Oman is one of the well-known contracting company provides Engineering services in Oil gas, petrochemicals and Fertilizer Companies in Oman and UAE.

HALDIA PETROCHEMICAL, HALDIA. One of the petrochemical company in Haldia, West Bengal India.

ADVANCED PETROCHEM, JUBAIL SAUDI AREBIA, is Petrochemical Industries.

RELIANCE INDUSTRIES LTD is one of the largest petrochemical industries.

Academic Details:

B. Tech Mechanical with First Class from Adarsh Management of Institute, Mumbai.

Diploma Mechanical Engineering from Technical Examination Board, Gujarat.

Date:

Place: Edison, NJ 08820 Maharshikumar R. Bhatt



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