PROFESSIONAL OBJECTIVE :
To associate myself with an organization that provides me an opportunity to show my skills and ability, improve my knowledge and to be a part of the team that works dynamically towards the growth of the organization.EDUCATIONAL BACKGROUND :
Completed M-Pharma (Pharmaceutics) from Rajiv Gandhi Technical University, Bhopal (M.P.), Bhopal in 2012 with 73.00%.
Completed B.Pharm. from Rajiv Gandhi Technical University, Bhopal (M.P.), Bhopal in June 2005 with 60.49%.
Completed Higher secondary (10+2) from Gov. H. S. School Venkat No. 1, Satna (M.P.) in Jun.2001 with 64.00%.PROFESSIONAL EXPERIENCE :
TOTAL 6.5 YEARS in QA (Formulation)1) Cadila Pharmaceuticals Ltd, Ahmedabad, (Guj.) :Duration : Apr – 2011 to till dateDesignation : Executive-QA2) Alembic Limited, Vadodara, (Guj.) :Duration : Sep – 2008 to Aug – 2009Designation : Executive-QA3) J.B. Chemicals and Pharmaceuticals Ltd., Ankleshwar, (Guj.) :Duration : Mar – 2008 to Sep – 2008Designation : Sr. Officer-QA4) Ipca Laboratories Ltd., Ratlam (M.P.) :Duration : Aug – 2005 to Feb – 2008Designation : Jr. Officer-QAAREA OF PREFERENCES :
Quality Assurance (IPQA, Validation, Quality Management System (QMS) & Documentation)
Drug Regulatory Affairs (DRA)CURRENT JOB PROFILE :
Exposure of Oral solid Formulations (Tablets & Capsules) -
To check & review Master BMR and Master BPR with respect to MFC & MPC for regulatory market and up gradation & implementation as per regulatory guideline.
Handling of ANDA activities for USFDA & UKMHRA (Submission batch protocol & report preparation, Sampling, Monitoring, Review of ANDA batch record, Analytical report, Product development report etc. as per regulatory guideline)
Preparation and review of Production & QA SOPs as per regulatory guideline which is observed during Gap analysis, periodic review, customer compliance.
Handling of market complaint as per regulatory guideline (Investigation of probable and assignable cause, CAPA handling and to impart training as per SOPs, Module base, on job, class room, conference and external).
Handling of Deviation, Change Control, OOS & OOT as per regulatory guideline
To check & review Product development files and report for regulated market
To check & review Analytical method validation data along with raw data.
To check & review stability trend for regulated market.
To check and review multimedia analytical data
To check and review vendor approval data for regulated market
To review dossier before submission to regulated market.
To check and approve the LIMS analytical data for regulated market.
Artwork and proof checking & approval of packing materials.
Having working Knowledge of Hold time study.
Monthly and quarterly trend data preparation of cGMP noncompliance observation.
Daily, Weekly & Monthly management review and submission to higher management during CFT meeting.PREVIOUS COMPANY JOB PROFILE :
Exposure of Oral solid Formulations (Tablet & Capsule), Liquid Orals as well as Injectables SVP (Ampoules & Vials)-
Exposure of Validation & Qualification as per regulatory guideline (Process Validation, Cleaning Validation, HVAC, Autoclave, DHS, Tunnel, Water system, Inspection activity, Washing machine of Ampoule & Vials,)
Review & closure of executed BMR and BPR with customer compliance.
Exposure of Product Quality Review (PQR) study as per regulatory guideline
Exposure of Temperature excursion study, Stability study, Data logger study.
Having working Knowledge Media fill activity (Process simulation study).
Risk assessment and impact analysis as per regulatory guideline.
Team leader of IPQA (To give training for various activities like line clearance, challenge test, IPQC, Failure investigation, cGMP non-compliance CAPA, Deviation, change control, market complaint, Incident report, OOS, OOT, Sampling management, AQL, Impact analysis, stage clearance, batch record review process, batch reconciliation, trouble shooting during in process check, Self inspection & Audit preparation etc. Sponsored links :
as per regulatory guideline)
Co-ordination and cooperation with Juniors, Colleague, Seniors, QC, Production, Engineering, Ware house, F&D & Pack F&D, Supply chain, Marketing, RA, Vendor etc. for timely release of batches, to reduce noncompliance and to achieve excellent result for the growth of organization.ACHIEVEMENTS :
Certificate achieved for “Train the Trainer”
Certificate achieved for “Total Quality Management”
To identify, arrange and conduct training as per regulatory guide line
Having exposure of cross functional team (CFT) member as a part of Viable vision Team (GOLD RAT).MAJOR REGULATORY AUDIT FACED :USFDA & MHRA Audit : (Tablets and capsules) with No any critical, Major & Minor observation.
WHO (Local & Geneva), MCC, ANVISA, TGA, GCC, MOH etc.
Pfizer, Ranbaxy, Heumann, Bluefish, Endo pharma, North star, Sandoz Canada and several other party and regulatory Audits for Export in US, Europe, Australia market and Various Regulatory authority.SELF PROFILE :
Good communication Skill, Positive attitude, Honesty, Sincerity, Hard work and Respect to others are the values I have learnt in my life.
To complete task in an orderly & planned way/ meeting deadlines.
To enhance & support subordinates personal & professional development, provide guidance & feedback regularly.Computer Knowledge : MS office excel, MS office word, MS office power points, Intranet & Internet, SAP etc.PERSONAL PARTICULARS :Nationality : IndianMarital Status : Married.Languages Known : English, Hindi, Gujarati, Urdu and Arabic.Hobbies : Listening music, Watching news, Traveling and Net Surfing.SALARY DETAIL :Present Salary : Available on request.Expected Salary : NegotiableDECLARATION :
I hereby confirm that the information in this document is accurate and true to the best of my knowledge.PLACE : AhmadabadDate :
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