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Second Class Quality Control

Location:
Ahmedabad, Gujarat, India
Posted:
July 31, 2021

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Resume:

Present address:-

Brijesh D Shah.

Tapovan-*, A* Building

Flat No 401,

Behind sindhi jwellers

Vapi-396191

Email: - adnzhl@r.postjobfree.com

Mobile No: -,942-***-****,816*******

Respected Sir,

Sub:-An Application for the post of manager in QC Department.

On the subject, I, the undersign, submit my candidature for the above post and would like to send my

Bio-Data for your kind consideration.

I hope you will consider me for the suitable post applied for and give me a chance for personal interview.

In the event of my selection for said post, I assure that I shall spare no efforts to satisfy my superiors with my sincerity and hard work..

Looking forward to a favorable reply and thanking you, I remain,

Sincerely yours

(Brijesh D shah)

RESUME

OBJECTIVE

Innovative technical professional with progressive experience using GLP concepts in pharmaceutical industry. Extensive Experience in Quality Control.

Resourceful and analytical skills with outstanding interpersonal, communication and organization skills. Demonstrated consistently high level of performance in a variety of progressively responsible and challenging task. Effectively working both independently and in team.

EXPERIENCE

SUN PHARMACEUTICAL INDUSTRIES LTD. DADRA

( Pharma Division Formulation Unit ) 15th July 2014 to 31st July 2021

(MHRA & US FDA Approved.)

Manufacture of Tablet,

Executive ( Quality Control ),

Job Profile :-

Handeling of of Analytical method validation and method Transfer.

Raw data review of Raw material, In process and Finished product.

OOS,OOT and Lab event investigation.

Audit trial review of all Instrument.

To check the working standard COA.

Audit trial review of Empower software.

Planning in review department.

Raw data review of analytical method validation and analytical method transfer.

Temple review of analytical method transfer and analytical method validation.

Training imparted to analyst as per CAPA

Knowledge of sophisticated instruments like

UV Spectrophotometer ( Perkin Elmer )

FTIR ( Perkin Elmer )

HPLC(Shimadzu,Waters,Agilent,Thermo)

UPLC ( Waters)

pH meter( Metrohm )

Karl Fischer Auto Titrator ( Metrohm )

Disintegration Test Apparatus ( Electorlab)

Dissolution Test Apparatus ( Electrolab)

Conductivity meter( Metrohm )

TOC analyzer

Amneal Life science pvt Ltd, (Parenteral Unit)

22nd August- 2013 18thJune-2014.

Manufacture of Injection

Sr. Executive ( Quality Control ),

Job Profile :-

Working in stability department with trend analysis.

To review test like Assay & Related substance & Dissolution on HPLC.

To review all physical tests.

Prepare a summary of all products as per respective specification and handover to RA Dept.

OOS and OOT.

Trouble shoot HPLC problem.

To review Instrument method and sample set before start analysis.

Calibration of all instrument as per yearly schedule

Experience working in Raw material, In process sample and finished product.

Testing of Cleaning sample of Equipment.

.

Alembic Pharmaceuticals Ltd, Panelav.Halol- Baroda.

(Pharma Division Formulation Unit) 30th December- 2010 6th August 2012 (US FDA & ANVISA Approved.)Manufacture of Tablet, Capsule, Sr. Executive ( Quality Control ),

Job Profile :-

Working in stability department as a reviewer.

To review test like Assay & Related substance & Dissolution on HPLC.

To review all physical tests.

Prepare a summary of all products as per respective specification and handover to RA Dept.

Knowledge of OOS and OOT.

Trouble shoot HPLC problem.

To review Instrument method and sample set before start analysis.

.

Knowledge of sophisticated instruments like

UV Spectrophotometer ( Shimadzu )

FTIR ( Perkin Elmer )

HPLC ( Shimadzu,Waters,Agilent,Thermo)

Karl Fischer Auto Titator ( Metrohm )

Disintigratin Test Apparatus ( Electorlab)

Dissolution Test Apparatus ( Electrolab)

Conductivity meter ( Metrohm )

Ph Meter ( Metrohm )

Unique Pharmaceutical Laboratories.

(A Division Of J.B.Chemicals & Pharmaceuticals Limited) Panoli-GIDC- Anklewshwar

(Pharma Division Formulation Unit) 01st November 2008 28th December 2010.

(US FDA Approved.)

Manufacture of Oinments,Injecatable, Tablet, Capsule,Gel

Officer ( Quality Control ),

Job Profile :-

Responsible for overall activity in quality control which includes :

Analysis of Inprocess Finished Product on HPLC.

( Related substance, Assay, Dissolution & Uniformity of

dosage unit on HPLC)

Analysis of raw material on HPLC.

( Related substance, Assay)

To Carry out Calibration of Balance.

To check the performance of coloumn & maintaining related documents.

Calibration of HPLC in Quality Control department and reporting related documents.

Co-ordination with production department and material department for timely released of material.

Checking of Inprocesss & Finished Product Report.

Analysis of process validation sample.

Handling of Reference standards and Qualification of Working standard and maintained related documents.

SUN PHARMACEUTICAL INDUSTRIES LTD.

Halol-Baroda Highway,Halol-389 350, Dist : Panch Mahal

BARODA.

( Pharma Division Formulation Unit ) 07th November 2005 to 22nd.Oct-2008

(MHRA & US FDA Approved.)

Manufacture of Injecatable, Tablet, Capsule,Inhaler,Nasal spray

Officer- I ( Quality Control ),

Job Profile :-

Responsible for overall activity in quality control which includes :

Analysis of Related substance, Dissolution, Assay on HPLC in stability Department.

To check the performance of coloumn & maintaining related documents.

Calibration of HPLC in Quality Control department and reporting related documents.

To carry out critical Analysis of Inahler,Nasal spray and anticancer

Drug Like Content Per spray, Emitted dose, Drug encapsulation.

COMED CHEMICALS LTD, RANIA, BARODA.

(Pharma Division Formulation Unit)

10th June- 2005 30th September-2005.

(WHO-GMP, ISO9001-2000 Certified )

Officer ( Quality Control ),

Job Profile :-

Responsible for overall activity in quality control which includes :

To carry out Analysis of Assay & Related substance on HPLC of Finished Product.

To check the performance of coloumn & maintaining related documents.

Calibration of all instruments in Quality Control department and maintaining related documents.

Co-ordination with production department and material department for timely released of material.

Medley Pharmaceuticals Ltd,Daman

(WHO-GMP, ISO9001 & ISO 2000 Certified )

30th July 2002 to 31st May 2005.

Supervisor (Quality Control).

Job Profile : 1) Responsible for overall activities in Quality Control department which includes :

a)Chemical Analysis of Raw Material, purified water, finished products as per pharmacopoeia and in house Procedures.

b)Chemical Analysis of Neurobion Forte Tablet inporcess and finished Products(Merck Products)

c)Regular Monthly Performance audits from Merck.

d)To check the performance of column and maintaining of related documents.

e)Calibration of all instruments in Quality Control department and maintaining related records and documents.

2) Responsible for preparation and maintenance of documents related to quality control, which includes

a) Preparation of standard operating procedures related to quality control and specification of Raw materials and Finished products

b) General documentation which includes preparation of certificates of analysis for export orders, preparation of rejection notes, preparation of monthly performance reports.

3) Co-ordination with production department and material department for timely release of materials and smooth flow of production activates.

4) Responsible for interaction with external laboratories regarding test results and timely release of material

5) Responsible for ordering chemicals, glassware and other miscellaneous items used in routine analysis.

EDUCATION

1996-2002 South Gujarat University Surat

M sc passed in April 2002 with Second Class.

B sc passed in April 1999 with Second Class.

Window 98, Dos, MS- OFFICE, Power Point.



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