quality control specialist

Objective: To secure chellanging mid-level position within pharmaceutical, biopharmaceutical, research

laboratory ephasizing the focous on utilizing my educational background and my experience in

Q.C, analyatical skills and production.

SUMMARY OF QUALIFICATIONS

● In depth knowledge of US FDA SUPAC guidelines, CFR, ICH guidelines and cGMP,.

● Sound knowledge and on hand experience on pharmaceutical manufacturing process

● Technical expertise in QC test ( HPLC for assay,dissolution,content uniformity, impurities)and other test such as water by Karl fisher, moisture by GC, TLC. Other techniquies such as UV vis, wet chemistry techniques.

● Technical expertise in Pharmaceutical Equipment Qualification like Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and creation of Protocol and Summary Report.

● Ability to interact positively with senior management and colleagues with tact and professionalism; celebrated for dedication and quality of work. Innate ability to analyze and present data to decision-makers while advising on mission-critical findings.

● Sound Knowledge in equipment handling and operation like Compression Machine, Auto Coater, Rapid Mixer Granulator, Fluid Bed Processor, and Grinding Mills.

● Proficiency with MS Office, Microsoft Word, Excel, Power Point.

EDUCATION

Master of Science in Pharmaceutical Manufacturing Dec. 2009

Stevens Institute of technology Hoboken, NJ

Key Courses:

● Pharmaceutical Manufacturing, Good Manufacturing Practices (GMPs) in Pharmaceuticals, Validation and Regulatory Affairs in Pharmaceutical Manufacturing, Bio-process Technology in Pharmaceutical Manufacturing, Pharmaceutical Finishing and Packaging, Introduction to Project Management, Quality in Pharmaceutical Manufacturing(Lean manufacturing principles) , Design and Management of Aseptic Pharmaceutical Manufacturing Processes, Engineering Economics and Cost Analysis, Biopharmaceutical Facility Design.

Projects and Presentations:

■ Determination of caffeine in soft drink by using HPLC techniques

Cartridge: 8 x 100 mm m-Bondapak C18 (a reversed phase column).

Solvent: 0.5% phosphoric acid in 40% aqueous methanol.

● Validation of new manufacturing process

■ Performed IQ, OQ, PQ and Process Validation

■ Prepared all required protocols and documentation

● User Requirement Specification for sterile vial filling isolators

■ Prepared functional, operational, performance, and general equipment requirements

● Architectural lay out of the facility making solid dosage forms

■ Prepared an Octagonal Design of the facility with material, equipment, and personnel flow

BACHELOR OF PHARMACY

Rajiv Gandhi University of the Health Science, Bangalore, India 11/2006

Bachelor of Pharmacy

PROFESSIONAL EXPERIENCE

SANOFI PASTEUR, swift water, PA, USA Starting date: 11th may 2010 to present

Job function: Quality Control Specialist

● Perform routine testing for in process and finished product(syringes and vials) by using analytical techniquies such as HPLC, UV vis, FTIR, dissolution and moisture by KF, GC.

● Perform Sterility testing by direct trasfer method and membrane filtration method, particulate testing by mass spectroscopy, pyrogen/endotoxin testing by LAL test.

● Perform Q.C testing within established standard test times and maintain quality and productivity at acceptance levels.

● Maintain properly laboratory computerized documentation as well as manually documentation as per GMP.

● Execute trouble shooting of instrumentation and maintain Q.C lab equipment in good working condition.

● Assist other colleagues with laboratory investigation , training of other analysts as assigned.

● assist with proper execution of laboratory out of specification(OOS) investigation, corrective and preventive action(CAPA)

Accent Microcell Industries Starting date: 5th of December 2006 to

Ahmadabad, India 10th of December 2007

Job function: Production Supervisor

Scheduling manufacturing activities as well as coordinating equipment maintenance and validation

Correct execution of production batch records and preparation of production variance reports

Technical problem solving, operational improvements, and efficiency improvements to reduce operating

Costs.

Manage to standards and manpower requirements to meet production requirements

Develop and maintain operator training programs and standard operating procedures

Development and performance management of manufacturing staff

Associations: International Society of Pharmaceutical Engineering, ask about Validation.com

Reference: Available upon request

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