Vidhi Patel
Souderton, PA****4
acbb3k@r.postjobfree.com
SUMMARY OF SKILLS:
. Great work ethics in adherence to GMP/GLP guidelines, FDA regulations
and company policies.
. Skilled in analytical chemistry techniques with significant knowledge
regarding Dissolution, Content and Blend Uniformity, Assay, and
Impurity testing of solid and liquid dosage form
. Experienced in analysis and operation various analytical
instrumentation such as HPLC, UV-VIS, GC, FTIR, Dissolution Apparatus,
KF, Horiba particle size detector.
. Proficient user of Empower, LIMS (Labware and Beckman), Turbo chrom,
Microsoft Office applications.
. Reviewed activities for approval of instrument qualification (IQ / OQ
/ PQ)
. Effective communication, project management, technical writing and
computer skills.
. Highly motivated, adaptable and trainable; able to quickly learn and
apply complex technical concepts.
WORK EXPERIENCE:
MCNEIL CONSUMER HEALTHCARE, R&D Senior Analyst (contract)
Feb 05 -- Present
Accomplishments:
. Accepted a challenging role in sample management group to receiving,
logging in LIMS database as per applicable study protocols, storing
and tracking of R&D samples.
. Developed IQ/OQ protocols and reports of various instruments as per
the cGMP requirements.
. Assisted in analytical method transfer for drug analysis using HPLC.
. Trained new analysts on a wide variety of methods and instrumentation.
Responsibilities:
. Deliver timely results through detailed project management and focus
to analytical issues, at the same time ensuring accuracy and
consistency.
. Develop, modify and validate analytical methods to support the
formulations, production intermediates and final products using
various instrumental techniques.
. Stability and release testing of solid dosage forms (extended and
immediate release tablets, gel caps, chewable) and suspensions/liquids
mainly using HPLC and dissolution.
. Perform physical tests such as density, hardness, pH, particle size,
moisture content by KF and viscosity.
. Document all experiments and results in a laboratory notebook in a
technically accurate and timely manner according to cGMP guidelines
and in-house procedures.
. Investigate out-of-trend and out-of-specification results.
. Write technical papers, protocols and validation reports.
. Review laboratory notebooks and validate data in LIMS-Fusion.
. Ship samples and maintain data for outsourced stability studies.
WYETH PHARMACEUTICALS, QC chemist Jun
04 - Sep 04
Accomplishments:
. Gained knowledge and experience working in a regulated GMP and GLP.
. Instrument maintenance and troubleshooting
Responsibilities:
. Analyzed raw material, in-process samples, finished products and
stability samples.
. Performed computer analysis of chromatographic results and utilized
LIMS to report results.
. Maintained a laboratory notebook in accordance with SOP's.
. Record, interpret and evaluated the technical data.
NUCLEIC ACID FACILITY AT THE UNIVERSITY OF PENN, Research Specialist
May 03 - May 04
. Synthesized and prepared unmodified and modified oligonucleotides for
biological research.
. Purified oligonucleotides by HPLC and analyzed by CE.
. Performed administrative functions such as data processing of
orders, keeping track of facility inventory, filing, billing and
customer service.
EDUCATION:
University of the Sciences in Philadelphia, Philadelphia, PA
Graduated in May 03
Bachelor of Science in Pharmaceutical Chemistry [pic][pic]