Product Compliance Associate (QA)

Reeta Hardasmalani ****, Lakeshore drive

Email: *********@*****.*** Santa Clara, CA 95054

Cell # 201-***-**** 408-***-****

PROFESSIONAL OBJECTIVE

To obtain a position in Pharmaceutical industry specifically in the area of Quality and/ or technical documentation

QUALIFICATION PROFILE

Synopsis

• Diverse educational background in Chemistry.

• Laboratory experience in Analytical Chemistry, Laboratory controls and technical support

• Special instrument skills in HPLC, GC, TLC, UV, IR and Wet analysis.

• Knowledge of pharmaceuticals, quality control and cGMP Practices.

• 5 years experience in Product disposition and supports Quality analysis, Production and testing of Products

Education

• Bachelors of Science in Chemistry :

Bombay University, INDIA

• Diploma in Computer System Management

Aptech Industries, Mumbai INDIA

Certificate of Accomplishment

• Completed Certification in “ Drug Development “

Temple University, Philadelphia

• Completed Red Belt Certification

• Presently attending ASQ related Course towards completing

CQA Certification

Computer Skill

• Working Knowledge of SAP, Trackwise, LIMS

• Proficient in Microsoft Office, Windows Operating System

PROFESSIONAL EXPERIENCE

Wyeth, Pearl River, NEW YORK August 2004 – Present Quality Assurance Manufacturing Specialist

• Review Master Batch Records and Intermediates

• Performed Shop Floor duties such as logbooks, house keeping audits

• Release Raw materials and Polysaccharide batches

• Work closely with manufacturing operations, validation, support to the production and testing procedures.

• Review Protocols, Analytical results and documents associated with Investigations.

• Perform document review, data verification and other tasks related to regulatory filings.

BARR Pharmaceuticals New York Sept 2003 – April 2004

QC Chemist

• Performed analysis of generic finished products and Raw materials by USP, NF and in house test methods using HPLC, Dissolution, Carl-Fischer and Titration.

• Calibrated and maintained laboratory equipments, ensured

Compliance with cGMP

WYETH, Pearl River, NEW YORK May 2002 – Aug 2003

QC Chemist

• Performed routine analysis of pharmaceuticals in process and

Finished products by USP, NF and in-house test methods using

HPLC, UV, IR and wet chemical techniques.

• Train and assist less experienced staff in procedures, documentation of laboratory notebooks, use of instrumentation and all laboratory duties.

American Metal Recovery – KBF New Jersey Oct 2001 – April 2002

QC Chemist

• Responsible for the in process samples and finished products by in house test method using ICP and Wet Techniques and Titrations.

• Run, maintain and calibrate equipments for elemental analysis for all types (ICP) in GMP laboratory.

Chriomak Research Inc, New Jersey Feb 2001- September 2001

Chemist

• Performed routine analysis of pharmaceuticals in process and

Finished products by USP, NF and in-house test methods using

HPLC, UV, IR and wet chemical techniques.

• Conducted dissolution testing of solid dosage forms.

Hindustan Platinum Inc., INDIA July 1994 – October 1999

Analytical Chemist

• Responsible for the analysis of Raw materials, in-process samples and finished products by in house test methods using ICP, gravimetric and wet chemical techniques.

• Conducted physical and chemical testing of powder blend and finished powder.

• Calibrated laboratory instruments, prepared and updated standard operating procedures, reviewed analytical data and participated in product and process troubleshooting

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