YASHVANT MISTRY

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*,******** ******,

WESTFORD MA 01886

acc3jf@r.postjobfree.com 978-

***-**** (Home)

Seeking a position of with a growth-

oriented organization to fully utilize my education and experience

PROFESSIONAL PROFILE

Excellent knowledge of production,quality assurance, documentation in

Pharmaceutical

Manufacturing

In-depth knowledge of GMP, ICH, SOPs, ISO,USFDA quality management

system and internal and external audits

Team leader and team player, dedicated and result oriented professional,

proactive, multitasking

Self-Motivated, Hard working, Result - Oriented and ready to accept

challenge

Excellent mathematical, documentation, housekeeping and sanitization skills

Basic computer knowledge of Microsoft Office, Internet and familiar with

SAP (ERP) system.

Ability to work rotating shifts as well as weekend work

Adhered to GMP norms

RELEVANT EXPERIENCE

Perform quality of drug products during production trials (PDS) and

commercial batches to ensure that to meet standard of potency, purity,

uniformity, stability and safety at all stages of the manufacturing process

Conduct various processing operation i.e. blending, dispensing, binding,

grinding, milling, sieving, wet granulation, dry granulation etc.

Operate various kinds of equipments i.e. double cone blender, V-blender,

Planetary mixer, mass mixer, fluid bed dryer,spray dryer, granulator, tray

dryer, Quadro-mill, jet mill, micronizer, Quadro Vac. etc.

Maintains up-to-date training records on SOPs, GMP, and regulatory related

all documentation within the processing department.

Involved in effective implementation of quality systems, cGXP, SOPs and

regulatory compliance, process validations, equipment qualifications and

cleaning validations and quality assurance related areas

Investigated and reviewed nonconformance, out of specifications, out of

trend results, change control, planned and unplanned deviations

Coordinated implementation of corrective and preventive action plans

Computer skill: well versed with working on computer

Good decisions making and interpretation on technical related issues with

seniors.

Handled customer complaints and written CAPA for the deviation of products.

DOCUMENTATION SKILLS

Prepared and reviewed standard operating procedures, batch manufacturing

records, product change over cleaning records, specifications and test

procedures, product failure investigation reports

Prepared and reviewed qualification protocols and reports, validation

protocols and reports, annual product quality review reports and records

related to Quality Assurance departments

Provided documentation support to regulatory affairs department for

international product submission

Prepared and reviewed master product control record, site master file and

master validation plan, technology transfer documents

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MANAGEMENT AND ORGANIZATIONAL SKILLS

Supervised a team of more than 10-15 people and maintained high level of

activity, enthusiasm, teamwork and cooperation

Interacted with people of different departments at different levels for

effective accomplishments of quality assurance activities

Interviewed prospective employees

Compiled and prepared training schedule for the department and provided the

training to subordinates

Coordinated with manufacturing plants for preparation of customer and

regulatory audits

CAREER HISTORY

ASSISTANT MANAGER -PRODUCTION

Sterling Biotech Ltd.Baroda - India.

Oct'2010-Dec-21013

SENIOR EXECUTIVE -PRODUCTION

Cadila Healthcare Ltd.,Ankleshwer-India.

Apr'2008 - Oct'- 2010

EXECUTIVE PRODUCTION.

Sun Pharmaceutical Ltd.Baroda - India.

Oct'2006 - Mar'2008

SENIOR EXECUTIVE -PRODUCTION

Alembic limited.Baroda - India.

Sep'-2000 -

Oct'-2006

EXECUTIVE -PRODUCTION

Phlox Pharmacutical Ltd.Baroda - India.

Dec'-1998- Aug"2000

SHIFT PRODUCTION OFFICER

LUPIN LABORATORIES LTD,Ankleshwer-India.

Feb'-1994- Dec'-1998

PRODUCTION SUPERVISOR

Platewel Processes & Chemicals Ltd. Baroda - India.

Aug'-1986 - Feb'-1994

EDUCATION:

Master of Science (M.Sc) with Organic Chemistry - INDIA

1987 - 1989

Bachelor of Science (B. Sc.) with chemistry - INDIA

1981 - 1985

Diploma in computer programming, INDIA

2003 - 2003

EXTRA-CURRICULAR ACTIVITIES

Working in an Operation Excellence team to improve productivity and

Capacity.

Attend various types of training i.e. preventing product mix-ups, cGMP

fundamentals, WHMIS, LOTO (Lockout - Tag out), GMP sanitation,Active

workshop

Certificate in-house training for Dispensing, Granulation, Compression

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