Respected Sir,

Sub: Application for the post of suitable position in Quality Assurance

(Sr.Executive or Asst.Manager or Dy.Manager ).

Being given to understand from the source that there is vacancy in

your renowned organization, I wish to offer my candidature for the post

applied. If you favor me with an opportunity, I shall do best to work to

the entire satisfaction of my superiors and prove an asset to your

organization.

I shall very much appreciate an opportunity for a personal interview,

so that I may furnish you with more details. I have confidence that I can

meet the standards set for myself and fulfill your expectations.

I wish you kindly oblige and consider my application favorably.

Looking forward to be a part of your organization.

Thanking you,

Yours sincerely,

Manjunath

Residential Adress :

Permanent Adress:

C/O Vinayaka Complex

S/O Krishna Nayak P.K.

1st Fllor,Room No.109/10

#1-16-2,Near Bus Stop

Surjapura road,Attibele,Anekal T.Q

Madaga,Athradi,Parkala,

Bangalore-562107.

Udupi,Karnataka-576107.

. CAREER OBJECTIVE:

To achieve a senior position in Pharmaceutical industry,where I can

initiate my skills and abilities to improve the Quality systems and

strength of Pharmaceutical Organisation.

. EXPERIENCE:

Total Experience : 8.3 years in Quality Assurance Department ( IPQA &

Documentation).

From APR.2008 to till date :

Working as "Sr.Executive" in Quality Assurance Department, MICRO LABS

LTD, Hosur ( Formulation Unit : Solid Oral-Tablets & Capsules).

Company Profile: Micro Labs Ltd,Hosur is accredited by UK-MHRA, WHO, ANVISA-

Brazil, MCC-South Africa, TGA-Australia and Health Canada. Developing and

Manufacturing various Pharmaceutical Products - Tablets and Hard Gelatin

Capsules.

From Dec 2005 to Mar.2008 :

Worked as a QA Executive in WINTAC Ltd, Nelamangala, Bangalore (Formulation

: Parentral and Solid Oral-Tablets & capsules).

Company Profile: Wintac Limited,Nelamangala is accredited by French-FDA and

Local FDA. Developing and Manufacturing various Pharmaceutical Products

under lone licence - Parentral Formulation (SVP & LVP) Eye Drops and Nasal

Drops,Tablets and Hard gelatin Capsules (Pellet & Powder form).

. AUDIT FACED:

MHRA, WHO, WHO-MHRA Joint inspection,and Customer Audits.

Customer audits-Milpharm UK, Morningside UK, Batavia Export (EU-GMP), BB

UK, Neogen, Mylan, Australia,Ennogen Pharma,Teva UK,Sanoffi Aventis and

Somex UK.

. CURRENT JOB PROFILE:

SOLID ORAL DOSAGE FORM (TABLETS &

CAPSULES)

. Perform Annual Product Quality reviews in compliance with cGMPs, SOPs and

Regulatory requirements on all the products manufactured in Micro Labs.

. Responsible for devising schedule and execution of Self inspection as per

cGMP requirements.Preparation of Audit report, follow up & review of

audit compliance, Corrective and Preventive action for the Non-

conformances and Audit Closure.

. Involved in Regulatory and Customer audit compliance activity and follow

up to meet the compliances date.

. Execution of Process validation activities related to new and existing

process as per commitment in the Validation Master Plan.

. Reviewing of Executed Batch documents, Process validation report,

Certificate Of Analysis,and Product deviations for compliance before

batch release or submitting to regulatory authority and customer.

. Handling of Quality Management System such as Change controls,

deviations, OOS,CAPA,Market complaints and Non-Conformances.Trending of

QMS as per the procedure.

. Involved in investigation of deviations, out of specifications & Market

compliants.

. To ensure all changes are approved prior to implementation and all major

changes are made effective after adequate study with supporting

documentation. .

. Review of Technology transfer documents.

. Preparation and Review of Master documents such as Batch

documents,Process validation protocols,Stability protocols,Cleaning

validation protocols,Hold time protocols and Qualification protocols.

. Preparation and review of Site Master File (SMF),Quality Manual and

Validation master plan (VMP).

. Monitoring vendor approval process for Raw and Packing materials.

Preparation of vendor audit schedule, Approved vendor list and vendor re-

evaluation. Coordinating with vendor for vendor related documents such as

TSE/BSE, GMO, Heavy metal, residual solvents certificate, Manufacturer

and supplier questionnaire etc.

. Prepare, Review, Revise and implementation of Quality Assurance

procedures such as Self inspection,Product Quality Review,Change

control,Deviations,Out of specification etc. to make inline with current

requirement and as a part of audit response.

. Review of SOP's related to Human Resource,Stores,Production,Packing and

Engineering before effective.

. As a IPQA In-Charge, monitoring IPQA activities in Stores,Manufacturing &

Packing as per the standard operating procedure through IPQA's.

. Responsible for Regulatory Submission Activities (MHRA,WHO,Mexico,TGA,MCC

& Russia). Reviewing of regulatory submission documents such as Product

Development Report,Analytical Method Validation Report,Master and

executed submission batch documents before submission.Handling of

regulatory queries raised by the assessment team of regulatory body

during review of submitted dossier (Quality part of review) and providing

satisfactory response in co-ordination with respective department (Site

and R&D) to Regulatory affairs.

. Invololved in New Product commercialization and verifying fulfillness of

Post approval commitments that is made during dossier submission.

. Reviewing of stability data before submission to the customer or

Regulatory Authority.

. To establish and monitor the quality system for the manufacture, packing,

testing, storage and distribution of finished drug products.

. Conduct Gap Analysis for written procedure vs. actual procedure and

evaluate its risk assessment.

. To identify the training needs of department personnel based on

competency matrix and evaluate effectiveness of training.

. Handling of licenses, variation approvals, Technical Agreements and

Contract service Agreements.

. To co-ordinate with RA for variation filing to MHRA.

. Preparation and review of Calibration planner and also monitoring of

calibration of IPQA instruments.

. Monitoring calibration & Qualification activities.

. PREVIOUS JOB RESPONSIBLITY : QUALITY CONTROL & QUALITY ASSURANCE

PARENTRALS (INJECTABLES- SMALL VOLUME & LARGE VOLUME,EYE & NASAL DROPS,

TABLETS & CAPSULES (PELLET FORM)

. IPQA activities mainly in Parentral department (Small volume and Large

volume), Ophthalmic, Capsule & Tablet department.

. Sampling & Analysis of Water, Raw & Packing materials,Finished and Semi-

Finished products as per IH,USP,BP,EP & IP specification. Preparation of

Working standards.

. Process validation of Parentrals..

. Reviewing of Analytical reports.

. Dissolution of capsules in pellets form.

. Handling and Calibration of Instruments like UV Spectrophotometer,

Refractometer, Viscometer, Autotitrator, Osmometer, pH meter, Total

Organic Carbon Analyzer, FTIR, Polarimeter, DT & Dissolution tester, KF

titrator,HPLC and Friabilator.

. COMPUTER SKILLS:

MS-OFFICE,MS-WORD,MS EXCEL, POWER POINT and INTERNET

. ACADEMIC PROFILE:

Courses Institute Date of University Class

completion obtained

B. Manipal College of Oct. R.G.U.H.S, Bangalore 63 %

Pharmacy Pharmaceutical sciences 2004

Manipal PU college JUN.1999 Department of 65 %

PUC Manipal. Pre-university

Education

Parkala High School, APR.1996 Karnataka Secondary 75%

SSLC Parkala.Udupi Education Examination

Board

. ACHIEVMENTS:

. I had Faced WHO-MHRA Joint Inspection and Customer Audits such as

Ennogen,Teva Uk and BB UK by representing " Product Quality Review,Self-

Inspection and Batch Documents Review Procedures. Inspectors appreciated

systems and records.

. I introduced Statistical calculation such as Cp and CpK to check process

capability in Product Quality Review and Trained all concerned personnel

on the Same in Micro Labs.

. Taking a key role in IPQA during audit and explained auditors on IPQA

role to have better quality product.

. PERSONAL DETAILS:

Father's Name : P.K Krishna Nayak.

Languages Known : English,Hindi,Kannada and Konkani.

Date of Birth : 19th January 1981

Sex : Male

Nationality : Indian

Marital Status : Married

Hobbies : Playing Cricket, Chess

and Listening Music.

Present CTC : 4.2 Lack/Annum

Notice Period : 1 Month

. DECLARATION:

I hereby declare that the above-furnished details are true to the

best of my knowledge and belief.

Place:

Date:

(Manjunath)

Contact this candidate