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PARIKH KHUSHBU H.

: PERSONAL DETAILS:

Address : B-2,MEGHANAGAR SOC.7/1,

NEAR NALANDA-1,

WAGHODIA ROAD,

VADODARA-390019,

GUJARAT, INDIA

Tel (Home) : (026*-*******

Mob no : 099********

Email : adm35p@r.postjobfree.com

Date of Birth : 19th Aug 1989 Gender : Female

Nationality : Indian B-Group : ‘O’+

: EDUCATIONAL BACKGROUND:

M.SC MICROBIOLOGY FROM SARDAR PATEL UNIVERSITY WITH 60% IN APR - MAY 2013 MEDICAL LAB TECHNICIAN (M.L.T) FROM GUJARAT UNIVERSITY WITH 75% IN OCT- 2010 B.SC MICROBIOLOGY FROM SOUTH GUJARAT UNIVERSITY WITH 54% IN MARCH - 2011 H.S.C SCIENCE STREAM FROM G.H.S.E.B. GANDHINAGAR WITH 46% IN MARCH - APRIL 2007 S.S.C FROM G.S.E.B. BOARD GANDHINAGAR WITH 75% IN APRIL- MAY 2005

: CURRENT EMPLOYMENT: (SEP’19 TO TILL DATE)

At present working in Bharat parenteral limited, jarod Vadodara in QA department as a Sr. officer QA

Role & Responsibilities (QA):-

• To prepare and review of standard operating procedures and standard instructions

• To maintain the document data control.

• Prepare All activity like change control, customer complaint, deviation, CAPA.QMS

• To issue the change control form to user department and do the impact assessment for same.

• To issue the planned deviation or unplanned deviation form for any approved system or process deviate and investigation and root cause find out for the same.

• Investigate the root cause analysis of customer complaint and send the reply within time frame.

• Maintain the log of change control and deviation and close within time frame

• To prepare the self-inspection schedule and raise the corrective and preventive action for user department.

• Preparing and review of Qualification and validation protocol and report.

• Prepare a Validation master plan for qualification and validation activity

• Prepare the equipment qualification protocol and report and execution activity.

• Prepare a media fill execution activity, protocol and report for injectable Sterile product.

• To phase the external or customer Audit.

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• Review and approved the artwork of all dosage form.

• Sop related training given to Quality person.

• Prepare the APQR for every yearly products.

: PAST EMPLOYMENT: (NOV-16 TO SEP-19 – 3YEARS)

Worked in “AMOLI ORGANICS PVT. LTD”, PADRA in QA department as a “OFFICER - QA’’

( Nov – 16 to september- 19)

Role & Responsibilities (QA):-

• Preparing, review, issue and archival of Standard Operating Procedures (SOP), work instruction and standard formats.

• To review, issue and archival of specification and Method of analysis.

• To issue the change control format and fill the details and follow up for the closing of change control documents.

• Maintain the change control register.

• Overall document control including destruction of document after end storage period, distribution, archive of the document during revision.

• Handling of internal and customer audit or regulatory audit.

• Issuing of line clearance at every step of batch manufacturing.

• Conducting the In Process inspection for the same.

• To do why and root cause analysis for the problem and rejection coming on line.

• As per the planning sheet take the follow-up of the documents to particular departments for BMR and release the COA.

• Shop floor round daily for GMP Practices.

• The GMP practice in production and packing area day to day basis effectively.

• Give the training of GMP (Good Manufacturing Practice), GDP (Good Documentation Practice), Quality policy, QMS (Quality Management System) to the new joining.

• Prepare the management review meeting (MRM) in every six month.

• In the internal or external audit raise the CAPA related observation with proper justification and maintain the log book.

• Issuance of QMS document and control the same.

• To close out the change control, deviation, corrective and preventive action report, market complain, document destruction form update the log and maintain the report for the same.

• To handle the market complaint and close it out within time frame.

• In market complain recheck the quality documents and investigate the probable root cause. Fill the customer complains form and revert back with proper Corrective and Preventive action. Page 3 of 4

: PAST EMPLOYMENT: (Oct 13 to Oct 16 (3 years))

Worked in SCHOTT KAISHA PVT. LTD, Jambusar, vadodara from Oct 13 to Oct 16 (3 years) as a Sr. Executive QA.

• To prepare and review of standard operating procedures and standard instructions

• To maintain the document data control.

• Prepare All activity like change control, customer complaint, deviation, CAPA.QMS

• The GMP practice in production and packing area day to day basis effectively.

• Give the training of GMP (Good Manufacturing Practice), GDP (Good Documentation Practice), Quality policy, QMS (Quality Management System) to the new joining.

• Prepare the management review meeting (MRM) in every six month.

• To do the calibration and validation activity with outside party.

• Shop floor round daily for GMP Practices.

Worked in “DEVINE” Pathology Laboratory, Vadodara. (JUL’13 TO OCT’13)

: ACHIVEMENT:

Got the award of best employee of the year in 2015 in Schott Kaisha Pvt. Ltd.

: INDUSTRIAL TRAINING:

3 Days industrial training of ISO 15378 GMP certification.

: MISCELLANEOUS:

PRESENTED SEMINARS/PAPERS:-

Seminar on “R-DNA technology,

Seminar on Immunology,

Seminar on Enzymologist.

Seminar on fermentation.

INDUSTRIAL TRAINING:-

Performed a vocational training at, FOOD & DRUGS LABORATORY, Vadodara From 4th June 2012 to 15th June 2012.

Performed training at, ‘’VRAJ’’ PATHOLOGY LABORATERY, Vadodara From 4th March 2010 to 3rd Sept 2010.

INDUSTRIAL EXPOSURE:-

Cheese/Paneer Production Plant, Khatraj, Nr. Anand.

Plant Research Center, Boryavi, Anand.

COMPUTER EXPOSURE:-

MS Office – WORD, EXCEL, ACCESS, POWER POINT

LANGUAGES KNOWN: -

1)English 2)Gujarati 3)Hindi

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HOBBIES: -

Listening Music, Making Friends.

STRENGTHS:-

Result Oriented & Positive Approach.

Knowledge of control of non confirmance.

Good Communicating Skill & Convincing Power.

Good Problem Solving & Analytical Skill.

Continuous Improvements & Learning Approach.

Good Interpersonal and Team skills.

I assure that the above-furnished details are true to the best of my knowledge. I wish to prove myself at work, under your kind guidance. KHUSHBU H. PARIKH.

997-***-****)

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