Manager Quality

Covering letter

From:

Satish T Nayak

D.No. 190, Honnashree Nilaya, 11th Block,

Bhanashankeri 6th stage, BDA layout,

Srinivasapura, Bangalore-560060.

KARNATAKA . INDIA

To:

Respected Sir,

I wish to submit my Resume for your kind perusal and would appreciate the chance to explore this opportunity further with you in person.

Thanking you for your consideration.

Yours Sincerely,

Satish T Nayak

Satish T Nayak

D.No.190, Honnashree Nilaya, 11th Block,

Bhanashankeri 6th stage,BDA layout,

Srinivasapura,Bangalore-560060.

KARNATAKA .INDIA

Mobile : 988*******

Mail : *********@*****.***

Carrier objective

Looking forward to a challenging position where and can handle a QA /QC department and supervise them to achieve better result for the overall oganisation. I would like to enhance my skills and utilise my creativity for the advancement for the organisation

Objective

Contribute to the sucess of an innovative organisation and work with talented indiviuals in the manufacturing, engineering and quality disciplines .

Summary of qualifications

Over 25 years experience in the pharmaceutical industries utilising cGMP guidance and FDA regulations to create quality products.

Participated in numerous successful compliance audits like NDA(UGANDA), WHO GMP, EU acridation,,MHRA, MCA, TGA and local regulatory compliance, face to face & behind the scenes.

Performed numerous internal, Material supplier and third party quality audits.

Develped and organised quality documentation systems like SOPs, Change controls, Deviations, RCA, Risk assesments, Complaint management, CAPA, IQ,OQ and PQ Validations of equipments and instruments, proccess validations. Hands on validation on packaging and manufacturing equipments.

Developed compliance training systems where department manages and partner in the creation and review of training requirements by job functions and assess indiviual and department compliance performance .

Developed standard training modules and trained employees in the areas of SOPs, cGMP, clean room technology, solid dosage forms,Liquid orals, Packaging / Labelling as per the current regulation requirement .

Improving overall product quality and increasing the facility prouction capacity .

Increase the yield of products by controlling inprocess visualance & checks and completed the project management duty for the many of small to intermediate sized capital equipment projects on time and on budget .

Implemented current GLP to meet the D&C Act, in quality control department .

Implemented comprahensive sample management system in the QC department .

Stability study management system made in place as per the requirement of ICH guidelines .

Out of specifications, rejection of materials management systems kept in place .

Controlled wearhousing system and upkeep of housekeeping systems .

Active participation in the HVAC validation programe .

Monitoring and controlling of EHS management system .

Control of Release and distribution of products as per the requirements .

Communication to the client and providing their requirements on time .

Leadership participation in all customer audit and made them success.

Responsiblity for handeling of QRM meetings and presenting the needful data to the management.

Work with team members to assist with carrier development and achievement of corporate and department goals.

Develops the calender and schedule management .

Budget development, negotiations and management .

Create and foster a working environment that is personally and professionally enriching.

Liaising with collegues to lead, advice and contribute on their work .

Co-ordinate health and safety trainig sessions and work place health and safety procedures as per company standards.

Supporting or trouble shooting the pipeline and work flow tools

Skills

Knowlagable and approachable with demonstrated ability to drive to clear action and ownwership .

Excellent technical knowledge and good understanding of scripting (visual and writing ).

Excellent computer skills with strong proficiency in Windows interface, microsoft office (Word, Excel, Powerpoint and Outlook).

Proficiency in english (good communication skills, abiity to draft technical documents ).

Ability to apply detailed knowledge of organisational procedures to make independent decisions and serve as a credible resource for a senior management .

Strong leardership skills, able to influence and drive results through the organistion and stakeholder management .

Audit Faced

WRC, TGA, UK MCA, MCC, Uganda (NDA) and International audits like GSK, Pfizer etc.

Instruments Handling

H.P.L.C.

FTIR

U.V. Visible Spectrophotometer Potentiometer

K.F. Titrater

Polarimeter

Photoflourimeter

G.C.

Dissolution rate test apparatus.

TOC

DO Meter

Work history

M/s Remidex Pharma Pvt.Ltd Bangalore-560058.

Job title : Sr.Manager QA/QC November 2009 to till date .

Worked as Sr. Manager – Q.C. in M/s. Global PharmaTech Pvt. Ltd., from May – 2003 to November- 2009.

Worked as Quality Control Executive in M/s. Medreich Sterilab Ltd. from April 2000 to April - 2003.

Worked as Quality Control Officer in M/s. Cipla Ltd. from Dec 1999 to April 2000.

Worked as Senior Quality Control Chemist in M/s. Kemwell Ltd. from August 1993 to Dec 1999.

Worked as Chemist in M/s. Sahyadri Starch & Chemicals Pvt. Ltd., from June 1990 to August 1993.

Qualification

M.Sc, Organic chemistry : From Karnataka University Dharwad .

General

Date of Birth : 21.06.1965

Father’s Name : Timmanna Nayak.

Marital Status : Married

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