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Quality Control

Location:
Dayton, NJ, 08810
Salary:
$32
Posted:
March 29, 2024

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Resume:

Dipeshkumar Sathwara BSc, MSc Industrial Chemistry,

ad4nnv@r.postjobfree.com 732-***-**** A-13 East Garden Way Dayton, NJ 08810 EDUCATION

● Master of Science in Industrial Chemistry (MSC) (Year 2010-2012) Sardar Patel University securing 2.77 GPA Vallabh Vidyanagar, India

● Bachelor of Science in Industrial Chemistry (BSC) (Year 2007-2010) Sardar Patel University Securing 2.78 GPA Vallabh Vidyanagar, India Summary

Analytical Chemist will be engaged in the different laboratory testing using a range of analytical equipments and techniques within GMP Laboratory

SKILLS

Excel, PowerPoint, Microsoft office and Document Archives. PROFESSIONAL EXPERIENCE

Pharbest Pharmaceuticals, Inc. (Chemist- Quality Control; November 2022 – Present)

● Perform assigned task related to the physical chemical tests as per In house written procedures compendial monograph for the Raw material, Active pharmaceutical ingredients, In process, Finished and Stability product using various wet chemistry physical and instrumental techniques such as HPLC, UV- vis spectrophotometer, IR, KF autotitrator and other routine QC instruments

● Performed In house Standardization

● Performed Calibration e.g Dissolution, FTIR, UV Spectrophotometer, Disintegration

● Support process improvement project such as standardization of test method

● Document work clearly and perform tests accurately record data and results as specified in documentation procedures

● Maintain proper laboratory logbook, notebooks and other records all the time

● Notify Lab Manager/QC director regarding any discrepancies in testing related to finished products & raw materials.

● Sound knowledge regarding GLP & GMP

Core Pharma Piscataway from March 2020 to October 2022 as a QA Associate. The Quality Assurance Associate is responsible for performing activities within Quality Assurance as explained below. This position also contributes to the completion of routine technical tasks and any additional quality task identified.

● Maintain Employee Training documentation in support of training matrix and internal SOP requirement.

● Batch record reviewing and providing required approval for manufacturing activity and making appropriate entries in the batch record.

● Document handling (i.e Change Control, Deviation, CAPA, OOS,OOT,STP, Planned Deviation, Product Complain etc..)

● Participate in Documentation Closing process after the investigation is done.

● Verify raw material and components prior to usage as required and check and monitor the dispensing/weighing process.

● Perform and monitor manufacturing floor QA related functions.

● Perform IPQA testing on the manufacturing floor.

● Check cleanliness and provide usage approval of equipment and line clear.

● Maintain Master SOP binders and Historical SOP Binders (Physical and electronic)

● Maintain QA documentation retention areas to ensure documentation is available for regulatory and quality review, as required.

● Assist internal and regulatory inspection towards employee training and document support.

● Review, approve, track, scan, and file all GMP related documents.

● Administrative support towards Product Quality Complaint Process.

● Provide additional administrative support as required from various departments.

● Work with GMP departments to ensure training is completed to support SOP deployment.

● Sampling of Raw material and Packaging Components.

● Maintain Retain sample and document control room. PROFESSIONAL EXPERIENCE

ATUL LTD, Valsad, Gujarat, INDIA from July 2012 to March 2016 as an Chemist.

● I have handled the DCS in continuous process & Unit Operation during which I dealt with the following function.

● Shift/General -Daily scheduling work/ Planning.

● Ensure safe process going on in the plant and also monitor & maintain all process parameters as per SOPs and cGMPs

● Raw material stock handling, Finish product stock report maintaining work.

● Responsible for performing my work in terms of quality & quantity by maintaining parameters.

● Overseeing production related tasks including planning, control & troubleshooting for achieving the planned quantity and periodic schedules

● Receiving the various permits in daily maintenance work and supervising

● Achieve maximum production with required quality by effective utilization of equipment and materials and to work with and execute to carry out batches & decreases time cycle in the plant.

● Take intensive care to present solvent losses & get maximum solvent recovery.

● Handling shift, coordinating and supervising team of 15 person for effective and safe operation

● Discuss plan and periodic work with Team members and Superiors.

● Have knowledge of proper safety systems (PPE).

● Maintain daily reports & filling usage log books etc.

● Safe and effective handling and supervising of unit processes and unit operations like controlling electrolysis, absorption, evaporation, drying, heat exchanger, jet ejector, filtration, liquefaction, condensation & DM unit etc.

● Have experience in chloro-alkali plants.

● Process modification in caustic plants for more effective operation.

● Familiar with study, development and preparation of different Process Flow Diagrams

(PFD’s), Piping and Instrument Diagrams (P&ID’s)

● Major responsible for plant start-up, shut down, emergencies, trouble-shooting and cost reduction measures.

● Mass and Energy balance calculations.

● Preparation and review of Standard Operating Procedures (SOP) for assigned safe production operations and processes.

● Operational knowledge of DCS (Yokogawa).

● Handled Products like Sulfuric Acid, CSA, Caustic 32%, H2 gas, Cl2 gas/liquid, Sodium hypochlorite.

● Having experience in working with ORACLE.

OPTIONAL PRACTICAL TRAINING

● 38 days training at Tonira pharma Ltd at Ankleshwar in 2011. Worked with Tonira pharma based on ETP plant to clean water and remove toxic and non toxic materials which will do less harm to the environment.

● DISSERTATION Project work on preparation of “POLYMER WITH HELP OF ULTRASONIC WAVE”.

Reference: Available upon request.

DIPESHKUMAR L SATHWARA



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