CURRICULUM VITAE

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HIREN J PATEL

Mobile No.: 094********/ 081********

Email-ID: adnaxv@r.postjobfree.com

adnaxv@r.postjobfree.com

Intend to build a career where my education and achievements can be advantageous with my knowledge, work techniques, unique methods and skills to achieve desired goals of organization that I will work with. To make value addition & positive contribution towards promoting team spirit in meeting the objective of organization and own professional growth.

A self-motivated professional with good communication skill and mixing nature, with ability to work as part of team and also as an individual and to attain challenging position and in turn, put best possible effort for growth of an organization and self-development. NAME: HIRENKUMAR JASHBHAI PATEL

DATE OF BIRTH: 29th May 1990

SEX Male

LANGAUGES English,Gujarati,Hindi

MRRITAL STATUS Married

RELIGION Hindu

PERSONAL SKILLS Willingness Power of Learning & Working. HOBBIES Listening Music, Watching & Playing Cricket PERMANENT

ADDRESS:

Lal Daravaja ni Khadki, AT & PO-Ankhi, TA-Jambusar, Dist.-Bharuch, Pin No: 392150, Gujarat (India).

CORRESPONDENCE

ADDRESS

FF-109 ERR Complex, Near Madhuram Party Plot, Zadeshwar Road, Zadeshwar, Bharuch, Pin No: 392011, Gujarat (India) Career Objective:-

Personal Details:-

Present Salary :- 6.85 Lakhs,

Expected Salary :- As Per Company policy

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STANDARD BOARD/UNIVERSITY

PASSING

YEAR

PERCENTAGE

M. Sc.

(Analytical

Chemistry)

Sardar Patel University,

V.V. Nagar

April-2012 65.30 %

B. Sc.

(Chemistry)

Sardar Patel University,

V.V. Nagar

April-2010 65.60 %

H.S.C. GSEB Gandhinagar March-2007 56.80 %

S.S.C. GSEB Gandhinagar March-2005 80.14 %

Sound knowledge of Microsoft Office ((Microsoft excel, Microsoft word, Microsoft power point, LIMS 3.2.1 (Laboratory Information Management System), SAP Athena Quality module. I have total 9 years of experience.

1. Presently working with M/s. Zentiva Private Limited (Formerly known as Sanofi India Limited) as

“Assistant Manager” in Quality Control department, at Ankleshwar, Since July 2015. 2. Worked with M/s. Unique Pharmaceutical Lab. (A Division of JB Chemical & Pharmaceutical Ltd) at Panoli as a “Q.C. Officer” (July-2013 to July-2015) 3. Worked with M/s. Intas Pharmaceutical Ltd, Ahmedabad, Sez Unit at Ahmedabad as a “Q.C. Officer” (May-2012 to June-2013)

Managing the department in day-to-day activities of instrumental lab and Chemical lab in keeping all sorts record of the department as per cGMP.

Planning for testing activity for finished product, Raw materials and instrument section as per requirement.

Educational Qualifications:-

Computer Proficiency:

Professional Experience :-

Job Responsibility:-

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Job Responsibility (Cont.….):

Management of Simplification projects of Quality control.

Resolution to all Trouble shooting through out to Quality control.

To carry out The Finished product, Raw Material, Stability Sample, ONCO Product, Hormones analysis as per specification and as per specified Analytical method.

Preparation of Analytical specifications for Starting material, In-process & Finished products.

Preparation of Analytical log sheets for Starting material, In-process & Finished products.

To ensure the proper management of references and working standards for accuracy of analytical data.

Handling of OOS & OOT and Laboratory Incident Report Investigation.

Involvement to creation & investigation of Change control and events.

Management and Control of Documents, such as SOPs, specification, Master Documents.

Preparation of Annual product review (Supplier performance review).

Knowledge of GMP and regulatory requirements.

Key user of SAP Athena, to create the Worksheet and maintain material master in SAP Athena Quality module.

To maintain GLP and statutory records.

Qualification of laboratory instrument.

Plan, check and control instrument calibration, maintenance and utilization in totality.

Budget planning for the coming year & Lab Inventory management.

Regular co-ordination with Materials department and vendors about rejection and educated the vendor for better quality improvement in Raw Materials.

Preparation of monthly report and quality review meeting report.

Training with respect to lab activity and analysis to the new employee. Participate in several Regulatory Audit like,

MHRA, USFDA, Ukraine Government Audit (SAUFD), TGA (Australia), Russian regulatory audit (MOH), Medicines Control Council of South Africa (MCC), Taiwan FDA, Belarus GMP inspection, GQA audit of Sanofi Pharma (Internal), WHO GMP.

Regulatory Audits:

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HPLC – Shimadzu & Agilent

Dissolution - Electro lab-TDT-08L,TDT-14L, Lab India 14000

UV-VIS spectrophotometer- Shimadzu UV-1800, UV1900, UV-2450

Polarimeter (Jasco)

Auto Titrator (Metrohm)

Karl Fischer Titrano (899 KFT & 795 KFT, 890 Titrando)

Melting Point Apparatus (Lab India)

Obtained Food and Drug Approval for Physicochemical analysis from Food and Drug Admn. Gadhinagar, Gujarat state ( FDA Approved Chemist Certificate)

SAP Quality module- Key User (Implementation and management of SAP quality module at site, Master data management, Inspection plan Management, implementation of Retrofit project for formula calculation, Lab work sheet (ATR), Sampling instruction sheet through SAP)

LIMS- For Laboratory Information Management System

Phenix – For Change control, deviation and OOS/OOT managements

GEODE- for SOP, Specification and protocol management.

CADUCEE- For management of chromatography data (Empower 3)

Track Wise (A Sparta Systems solution) - For Change control, deviation and OOS/OOT managements

Young, energetic, hardworking with good communication skills, eager to learn. A result oriented and highly dynamic, versatile personality also able to work under high pressure until long hours. I hereby declare that the above-mentioned information is true to the best of my knowledge and belief. Place: Bharuch Yours Faithfully

(Hiren J Patel)

Instrument Handled:-Expertise Gained

Software Handling For Data Management:-

Declarations:-

Food and drug approval:-

Strength:-

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