Quality Control Plant

QUALITY CONTROL

VIMAL PATEL

** **** ***** ****, #** A Email: ***********@*****.***

Edison – NJ-8820-3360 Phone: 973-***-****

Major Strength

Skillful Analytical work

Expert in Review of analytical documents like, SOP, STP, GTP, Analytical Data,

Review of the Investigation report of Lab event, OOS, CAPA, Change Control &

Others

Sharp planning work for ANDA Submission

Preparation of Specification, STP, SOP etc.

Education.

Sardar Patel University V.V. Nagar, Gujarat, India

Master of Science, Department of Bio science, in year1993.

Instruments to be known

KF titration, U.V Spectrophotometer, Flow Cytometry,LOD, I.R Spectrophotometer, Hardness, Friability, Dissolution, Disintegration Tester, pH Meter, Moisture Analyzer, Water Activity ( By Paw kit) etc.

Experience

Aurobindo (Aurolife) Pharmaceuticals (USFDA Approved Plant)

August 2019 to September 2019 (East Windsor, N.J. USA) Quality Control Analyst

* Responsible to Review the Documents like SOP, STP, GTP, Analytical Data Sheet etc.

* Analysis of Finish products & Packaging Material as per SOP.

* Checking the Serialization No. like batch No., Barcode No. etc on Finished Products.

* Preparation of SOP, STP, GTP & Specification.

Reliance Private Label Supplement (NSF Approved Plant)

April 2018 to July 2019 (Edison, N.J. USA) Quality Control Chemist

⃰ Responsible for perform and maintain Finish Product & Stability Samples as per SOP.

⃰ sending outside the material for various test as per approved Specification & SOP.

* Responsible to calibrate the Balance every day.

* Perform Water Content/ Loss on Drying on Moisture Analyzer

* Handling the instruments like, U.V.-Visible Spectroscopy, I.R., L.O.D, Paw kit meter.

* Responsible for monitoring Temp. And Humidity data every day.

⃰ Responsible for perform Water Activity by “Paw kit meter”

* Maintain logbooks of incoming and outgoing materials.

* Wt. Variation of Tablet, Capsule, Soft gels.

* Disintegration of Tablet, Capsule.

* Preparation of COFA.

* Checking the Serialization No. like batch No., Barcode No. etc on Finished Products.

* Handling of Lab event, OOS, CAPA, Change Control etc.

Torrent Pharmaceuticals Ltd. (USFDA Approved Plant)

Nov 2016 to May 2017( INDIA )Quality Control Assistant Manager

(Raw Material/Packaging Material)

Responsible for Review the Analytical Test Reports, Specification, STP, SOP, & Change Control. Responsible for perform and maintaining Sampling of Raw Material and Packing Materials in warehouse, under RLAF as per SOP.

Responsible for maintaining Sampling of Retesting Materials after suitable time interval. Responsible for sending materials outside for testing if the instrument is not available in Premises.

Multi-task person with Strong problem solving and trouble shooting skills. Able to

Adopt and apply new technologies quickly and efficiently. Handling of Lab event, OOS, CAPA, Change Control etc. Checking the Serialization No. like batch No., Barcode No. etc on Finished Products.

Sun Pharmaceuticals Ltd. (USFDA Approved Plant)

September 2008 to Nov 2016 (INDIA)Senior Quality Control Executive – Data Reviewer

(QA For Q.C. / Packaging & Raw Material)

Responsible for maintaining Documentation of Analytical Test Reports as data Reviewer, SOP, ATP, Specification, Pack Style and Pack Style for ANDA Submission, Intended &Exhibit products, European Country, US Country & for Domestic & Row Country. Handling of Lab event, OOS, CAPA, Change Control etc.

Audit Faced of USFDA, MHRA, MCC, INVIMA-COLUMBIA, ANVISA-BRAZIL, KFDA

Responsible for perform and maintaining Sampling of Raw materials & Packing materials in warehouse, under RLAF as per SOP.

Checking the Serialization No. like batch No., Barcode No. etc on Finished Products.

Astral Pharmaceuticals Industries May 2008 to September 2008 ( INDIA )

Quality Control Officer

Responsible for perform Sampling of Raw materials &Packing materials in warehouse,under RLAF as per SOP

Elysium Pharmaceuticals Ltd February 2005 to May 2008 ( INDIA ) Q.C.Department Head (Finish Product)

• Responsible for maintaining Documentation of SOP,ATP, Specification, Pack Style and Pack Style for ANDA Submission, Intended & Exhibit products, European Country, US Country & for Domestic & Row Country.

• Responsible for Sampling, Testing, Checking & Reporting of Packaging materials and Finish Goods

Elam Pharma Pvt. Ltd August 2004 to February 2005 ( INDIA ) Senior Q.C.Chemist

• Responsible for Sampling, Testing, Checking & Reporting of Raw Materials, Packaging materials and Finish Goods

Indosol Drugs Ltd April 1996 to August 2004 ( INDIA ) Senior Quality Control Chemist

• Responsible for Sampling, Testing & Reporting of Raw Materials.

• Prepare test solutions, compounds, and reagents for analytical testing. Armour Chemicals Ltd March 1994 to April 1996 ( INDIA )

Trainee Quality Control Chemist

• Responsible for Testing & Reporting of Raw Materials & Finish Products.

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