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RESUME

A. MURALIDHAR

ADDRESS:

Plot No.: 5, House No.: 14-235 (Old 14-221/1), Mobile: 0091-09848831103 [Per.]

Raghava Nagar Colony, 0091-09392442138 [Res.]

Near Pochamma Temple

TKR Engineering College Road, Email : acd73q@r.postjobfree.com

Meerpet,

Hyderabad–500097

Andhra Pradesh, INDIA

CAREER OBJECTIVE

Seeking top managerial position in the areas of Quality Assurance & Regulatory Affairs, where my

educational potential and managerial experience matches the organizational growth and strength.

M.Sc. completed from Madurai Kamaraj University, Madurai in the year

EDUCATIONAL 2006

QUALIFICA

PG Diploma in chemical analysis and Quality Management [PGDCAQM] in

TION

Hyderabad Central University in the year 2003

B.Sc. from Osmania University, Hyderabad in the year 1993

DATE OF BIRTH

2nd May 1972

MARRITAL

Married, Two children

STATUS

TOTAL 21 Years in key positions in Bulk Pharmaceutical Industry [API]

EXPERIENCE

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• Established Total Quality Systems in accordance with

International standards.

QUALITY/REGULATORY

• Preparation & Filing of CTD/Drug Master Files in various

MANAGEMENT SYSTEM

formats (US, CTD and specific customer’s requirement) for

API’s’to USFDA, Korea FDA, PMDA,EDQM for COS,

Canadian & AFM for Japan Drug Authorities and

registration in various European countries for Marketing

Applications.

• Response on CTD/DMF queries to PMDA,EDQM, KFDA,

Korea and for Various customers.

•Preparation & Review of Site Master Files, APQR,QRM and

Master Formula Records [MFR] &Presented to various

customers.

• Involved as a team member for one USFDA audit and

Faced directly two other USFDA audits &EDQM audit. The two

companies have been obtained approval by USFDA.

• WHO-GMP Certification and its periodical Audit for

Renewal and involved as a team member for one KFDA audit.

• ISO 9001-2008 certification audit and its Periodical Audits

• Prepared AFM regulatory documentation and submitted in Japan

& got site accreditation certificate from Japan ministry & health.

• Faced several customer audits those are like, Astellas [Yamanouchi Ireland company limited], Iwaki- Japan, AAC

Corporation, Actavis AD, Zentiva SA., Pol phrma

Hospira, midas pharma, Alchem,Aristo pharma, Ranbaxy,

Dr.Reddy’s,Glen mark, Sanofy aventies, Quimica Sintetica, Teva,

Torrent pharmaceuticals, Lanza pharmaceuticals,

Norten Health Care, P&G, and several European companies like

Belupo, Bristol, Aspen,Technimide,Nurax pharmacy,Dexcel etc.,

• Planning & Execution of External lab &KRMs vendor audits.

• Preparation of training plans and training of employees and

Co ordination & evaluation and maintained records.

• Associated with Sr. consultants like Dr. Ganesh KB Prasad,

Dr. V.K.Bhalla, Dr. R. Marayya, and Mr. Y. Venkatesh etc.,

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•

PROJECTS Quality Control Laboratory & QA areas

• Preparation of Drug Master File &CTD’s’ at Sr. consultants, Hyderabad

• ICH Q7A at IPA Mumbai

TRAININGS

• ISO 9000 :2000 Series QMS Auditor/Lead auditor

IRCA certified training course by DNV at Hyderabad.

• Training on c GMP and US FDA questionnaire by Dr. Dollecek

AAC consultancy.

• Personal Productive Program (Five months course) LMI at Hyderabad

(Leadership Management International)

• Quality Management System and Environment Management System By M/s.

Det Norsky Veritas at Hyderabad

• Methods validation at Hyderabad by Waters HPLC

• Current Good Manufacturing Practice (cGMP) for Finished

Pharmaceuticals [3 days program] at Hyderabad

by Engineering Staff College of India.

• WHO/cGMP at Hyderabad, Training given by K.P.Petkar

Ujwal prabha consultants

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June- 2013 – AGM –Quality Assurance

to till now RA Chem Pharma Limited

POSITIONS

(FDA &EDQM Approval Plant

Jaggaiahpet

October- 2010 – Sr. Manager –Quality Assurance/RA

to June-2013 Covalent laboratories P. Limited

Hyderabad

January- 2010 – Sr.Manager –Quality Assurance/RA

to October-2010 SMS Pharmaceuticals Limited

Vizag. [Kandivalasa unit]

July 2000 – Manager –Quality Assurance/RA

December-2009 SMS Pharmaceuticals Limited

Hyderabad .

(An ISO 9001 –2000& WHO GMP Certified Company)

Promoted as Management Representative

in the year 2001

Promoted as Asst. Manager in the year 2003

Promoted as Manager in the year 2006

September 1994 – Officer – Quality Control

June 2000 Neuland Laboratories Limited, Unit-2,

(FDA Approval Plant - 1999) Pashamylaram

Hyderabad

Promoted as Officer in the year 1999

Promoted as Chemist from Jr. Chemist in the year 1997

April 1993 – Chemist – Quality Control

September 1994 Agni synthetics & New life laboratories limited

Hyderabad

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JOB Responsible for Quality Assurance / RA functions like

DESCRIPTIONS

• Preparation, Approval and review of quality documents like

Quality risk management, Validation Protocols &reports

(Process, Cleaning, Drying &Blending), Specifications and STPs, SOPs,

process flows, quality procedures, Validation Master Plan BPCRs,

MPCRs[MFR],Formats, etc.

• Handling of contract manufacturing activities

• Planning and conduction of trainings

• Correspondence to the Regulatory authorities and customers to meet their

requirements like Annual update of DMFs, Questionnaires Reply,

Complaints reply and technical information etc.,

• Planning & Review of product stability studies,

• Facing customer & regulatory audits.

• Preparation and review of Master Batch Manufacturing record

Including Quality Control related checks during processing .

• Annual Product Quality Reviews [APQR]

• Handling &Review of CAPA Effectiveness

• Release of API’s’ & Issue of Certificate of Analysis for the products

as Approved Analytical Chemist by Drugs control department.

• Review of process Equipment qualifications (DQ, IQ, OQ & PQ)

Water system &AHU System Validations & environmental

Monitoring, calibrations of equipments.

• Planning & Execution of validations for Mfg. Process including

holding study, drying validation, Analytical Test Methods

and cleaning validations.

• Handling of change controls, deviations, failures, non- conformances

out-of-specification results, customer complaints and Return Materials.

• Implementation of cGMP systems as per standard guidelines

• Monitoring & follow up total QC activities.

Management Representative

• Planning & Conducting of

o Internal audits

o External audits

o Vendor audits

o Management Reviews

o Customer complaint & returns reviews

o Production reviews

o Trainings

• Reporting to GM -QA on the performance of the

Quality Management System and any need for improvement.

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PRODUCTS The following Anti Fungal, Anti Ulcer, Anti hypertensive, Anti Obesity and Antibacterial,

KNOWLEDGE Antibiotic drugs are as follows:

• Ketoconazole, Itraconazole, Fluconazole & Lanoconazole

• Famotidine

• Enalapril Malate

• Doxazosine Mesylate

• Sibutramine HCl Monohydrate

• Ciprofloxacin HCl

• Ranitidine HCl

• Enrofloxacin

• Omeprazole Pellets

• Itraconazole pellets

• Lopinavir

• Cefixime

• Cefdinir

• Cefpodoxime proxetil

• Cefuroxime Axetil

• Meboverine,Drotavirine,Entacopone,Lamotrigine,Efavirenz,TrazodoneHCl

•

DMFs FILING USFDA - 2

• EDQM - 1

• Canada - 3

• Korea - 3

• Japan - 1

• ANVISA [Brazil ] - 6

• Regulatory information / requirements prepared and provided to Mexico,

Japan & Taiwan

• 12 products DMFs in CTD format prepared and given to several

customers

• Present : 10.5 Lakhs per annum

SALARY

• Expected : Negotiable

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