Seeking Entry level assignments in Quality with growth oriented organisation; preferably in Pharma or Biotech Sector

** *** ********** ** ******* Assurance and Quality Control.

Currently serving with M/S Gena Pharmaceuticals Ltd. Kolkata.

cGMP GLP audits, Regulatory affairs, internal audit and Regulatory Audit compliance, Batch Release, Conducting Training,QMS- CAPA,Risk assessment,Qualification, validation & Local FDA & CDSCO Licensing.

Performed Vendor audit for API & Excipients-Vashudha Pharma,Kerry Ingredients, Parabolic Drugs,Supria Lifscience,Vital Labs & Microwax Pharma chem.

Dy.Manager-QA

M/S Gena Pharmaceutical Ltd. Kolkata (India)

Sept 2014- till date

Role-Head Quality.

Lead role in WHO-local audit and compliance.

Manufacturer of Tablets, Capsules & Liquid Orals.

JOB PROFILE:

Successfully respond and compliance audit points of Lupin, Sunpharma, Cipla, Ipca and Local FDA audit.

Preparation and reviewed of drug application with all supporting documents for Local FDA &CDSCO Licensing.

Preparation of formulation and executed with all quality aspects.

Review and approved Validation Master Plan and Site Master File.

Review of Training Manuals and Training Calendar.

Review& Approved master Batch Manufacturing Record and Batch Packing Record.

Approve the 'Standard Operating Procedure' pertaining to manufacture and control of drug products.

Approve specifications, sampling instructions, test methods and other quality control procedures.

Ensure that internal audit (self - inspection) is performed and compliance is ensured.

Approve changes in the manufacturing process, specification, testing procedures, systems, operations, facility, documents etc.

Reviewed the Risk assessment of facility, method, system, process and materials & follow up.

Ensure that all the necessary in process quality assurance activities are carried out.

Ensure compliance of cGMP in the manufacturing, packing and release of drug products.

To review validations protocols and reports, prepare validation plan & Validation executed.

Approved the Qualification protocol, report of area, system and facility & implementation.

Ensure & review of completed Batch Manufacturing Records for critical process steps before release & responsible as Qualified person for Batch release for Market distribution.

Handling of quality related complaints are investigated and resolved.

Ensure that product failures are investigated and resolved.

Ensure vendor evaluation / audits of Raw & Packing Material suppliers & perform vendor audit.

Ensure that product sampling is performed as per Standard Operating Procedures.

Ensure that product / system deviations with impact & CAPA.

Ensure Product quality reviews are performed at regular intervals.

Verification of experimental record books and review of product specific protocol and reports for developmental studies.

Compilation / Review of development pharmaceutics prepared by the formulators for all markets. Review of TT documents & results.

Training to other Formulation development groups, as and when required.

Conducting training on GMP & need based.

Monitoring GMP in plant,

Implementation of quality system & minimise the quality gaps.

Total in process control & insure product mfg in design based.

Support the part of Stability, Process Validation & Analytical method validation for CTD.

Prepare the quality policy

Lead to 11 staff of QA & QC (Officers& Executives) and trained in there relevant jobs

Success fully renovates the facility, HVAC modification and approved the facility validation

Team Leader-QA

M/S Gracure Pharmaceutical Ltd. Bhiwadi-Rajasthan, (WHO, EU, GMP &TGA Approved)

Sep.2009- Sept.2014

Manufacturer of Tablets, Capsules, Ointment, Injectable, Liquid Orals & Beta-Lactum.

JOB PROFILE:

Review & approval of Validation Master Plan and Site Master File.

Review &approval of Training Manuals and Training Calendar.

Review& Approved master Batch Manufacturing Record and Batch Packing Record.

Approve the 'Standard Operating Procedure' pertaining to manufacture and control of drug products.

Approve specifications, sampling instructions, test methods and other quality control procedures.

Ensure that internal audit (self - inspection) is performed and compliance is ensured.

Approve changes in the manufacturing process, specification, testing procedures, systems, operations, facility, documents etc.

Reviewed the Risk assessment of system, process & follow up

Ensure that all the necessary in process quality assurance activities are carried out.

Ensure compliance of cGMP in the manufacturing, packing and release of drug products.

To review validations protocols and reports, prepare validation plan & Validation executed.

Reviewed the Qualification protocol, report & implementation.

Ensure review of completed Batch Manufacturing Records for critical process steps before release & responsible as Qualified person for Batch release for Market distribution.

Handling of quality related complaints are investigated and resolved

Ensure that product failures are investigated and resolved.

Ensure vendor evaluation / audits of Raw & Packing Material suppliers & perform vendor audit.

Ensure that product sampling is performed as per Standard Operating Procedures.

Ensure that product / system deviations with impact & CAPA.

Handling the Chang control with impact analysis & follow up for implementation.

Reviewed product quality reviews are performed at regular intervals.

Ensure e the laid down standard operating procedures (SOP) in the Formulation Development department, including laboratory safety.

Ensure &Review of the work done by the formulators.

Review of analytical data and further action plan related to project development.

Verification of experimental record books and review of product specific protocol and reports for developmental studies.

Compilation / Review of development pharmaceutics prepared by the formulators for all markets. Review of TT documents & results.

Training to other Formulation development groups, as and when required.

Conducting training on GMP & need based..

Monitoring hygiene in plant,

Implementation of quality system & minimise the quality gaps.

Total in process control & insure product mfg in design based.

Lead to 22 staff of QA(Officers & Executive) and trained there relevant jobs.

Executive-QA

M/S Mylan Laboratories Ltd. (Formerly Famy Care Ltd)-WHO Local, WHO Geneva, MCC, USFDA Approved, GIDC Sarigam, Gujrat Jun-2006-Sept 2009.

Prepare & reviewed the BMR, BPR, MFR & MPR

Prepare the Training Manuals and Training Calendar.

Review the master Batch Manufacturing Record and Batch Packing Record.

Handling of NCR, Deviation, and incident & Chang control.

Prepare the ‘Standard Operating Procedure' pertaining to manufacture and control of drug products.

Verify the new formula of the product & optimisation process.

Hygiene monitoring in Plant.

Perform the HVAC Validation,Calibration & review the report

Prepare the Process validation Protocols& reports

Prepare the Equipments qualification protocols & reports

M/S Mission Pharmaceutical Ltd. (WHO Approved) GIDC Sarigam. As QA officer from Feb-01 to May -06

In Process with critical control parameter checks.

Handling of HPLC,GC,UV.Visible Spectrophotometer &Dissolution apparatus.

Perform the Process Validation sampling & cleaning validation sampling.

Prepare the Standard operating procedure.

Review the MFR, BMR and MPR, BPR.

Participate in equipment,area,facility & process qualification & its documented.

Handling of NCR,Deviation,incident & Chang control

Chemist –QC

Mohan Pharmaceuticals Ltd.Ghaziabad.(UP)

Oct-1999-Jan-2001

Check the physical Process parameter.

Perform the water sampling & testing

Handling of UV Spectrophotometer & Gas chromatography.

Raw material sampling & testing.

ACADEMIC ACHIEVEMENTS

B.Sc with Chemistry from Purvanchal University Jaunpur UP.

PG Diploma in Pharmaceutical Chemistry from IGMPI New Delhi.

Training from Government Advance Training Institute Sion Mumbai.

1-Spectro Photometric Method of Analysis.

2- Analysis by Gas Chromatography.

Training & Certificate of Participation for-

1-cGMP training in 2007 by Mr G.D Asrani (IDMA Director) Mumbai.

2-Practice of Good Documentation in Feb 28th 2010 by S.W Kolhatkar.Mumbai.

3-GMP &EU GMP Principles in March-21th 2010.by S.W Kolhatkar.Mumbai.

4-Market &Product Recall in Oct 6th 2010 by Gery Demarteau. Belgium.

Audit Faced

Actively involved in the preparation for regulatory audits & Audit faced of WHO Geneva, Local WHO, MCC, Mylan Lab USA,USFDA, EU GMP.s & TGA.

PERSONAL VITAE

Father’s Name : Mr. Siyaram Yadav

D.O.B. : 15th Aug 1974

Nationality : Indian

Religion : Hindu

Marital Status : Married.

Language Known : English & Hindi

Hobbies :,Playing cricket &,Football

Permanent Address : 101- Maharaura -Kanwar

Distt: Chandauli (Varanasi)

U.P

Mob. No.096********,

REFERENCES

Dr. Vinay Pandey-(R&D Scientist-Grade-I) Glenmark Ltd. Nasik Maharashtra.

Mr. R.K Singh (VP-Operation ) Mylan Laboratories Ltd (Gujarat )

Notice period-30 days

Date:

Place:

( N. Yadav)

NAGENDRA YADAV

Mobile: +918*********,891*******,+917*********

E-mail: adnr0k@r.postjobfree.com, Skype ID.nagendra.yadav101

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