Quality Assurance Manager
Resume:
YASHVANT MISTRY
WESTFORD MA 01886
***************@*****.*** 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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***************@*****.***
978-***-****(Home)
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
Contact this candidate