Vishal Shingala

*** ******* *****, ***** *****, PA 19454 Contact # 267-***-**** Email- aczpb1@r.postjobfree.com

Career Objective

Seeking quality environment where my knowledge and experience can be shared and enhanced. Looking for an opportunity where I can improve as well as contribute my knowledge and technical skills in the organization.

Summary

Motivated and Dedicated Analytical Chemist with 4 years of experience in pharmaceutical industry also 4 years of experience in Pharmacy. Detail oriented and contribute work as a team and equally capable of working independently to accomplish goals within established deadlines.

Participated as Production, Packaging, QC and QA trainee in following pharmaceutical companies approximately 9 months:

Moxy Laboratories Pvt Ltd

Unique Pharmaceuticals Ltd.

Norris Medicines Ltd

Working knowledge of Electronic Laboratory Notebook, Open Lab, Midas, LIMS,Smart Lab, Empower software, Lotus Notes, ERP Systems, Class-VP IR-Solution, Lab-X, FTMS, Spectra Manager, Chemstation, Waters, Shimadzu, And Agilent.

Attended training in:

cGMP & GMP Trends

Validation

Inprocess Quality Control

Corrective and preventive action (CAPA)

Investigation of out of specification (OOS) results

Knowledge of IND safety reports and HIPPA guidelines.

Strong educational, knowledge and professional working background in FDA regulations including 21 CFR Part 11, ICH, USP/EP/JP regulations, GCP, EMEA, MHRA and other regulatory guidelines.

Extensive knowledge of drug safety and drug development process and procedures.

Proficient in data entry and excellent knowledge of ARGUS safety database.

Proficient with Microsoft Office and Internet.

Excellent research, analytical and problem solving.

Excellent in determining chemical and physical properties.

Strong in mathematics and troubleshooting skills.

Professional Experience

Eurofins Lancaster Lab-West Point, PA

Analytical Scientist (06/2016-Current)

Responsibilities included analysis of clinical release products, in-process samples, stability study, process validation, cleaning validation, and cleaning verification samples;Perform analytical testing such assay, impurities, dissolution, content uniformity, and blend uniformity, Swab samples, physical testing of solid dosage forms on (HPLC,UPLC, Spectroscopy, FTIR,GC,UV,Dissolution,KF-titrator,pH meter,viscosity,osmolality,water activity,Hadrness, Disintegration, etc.)

Perform method validation and / or method development according to the different projects

Under the direction of a more senior staff member, carries out routine GMP testing on pharmaceutical products..

Interpreting data and adhering to strict guidelines on documentation when recording data.

Write technical papers or reports or prepare standards and specification for processes, facilities, products, or tests, transfer data to RLIMS and review electronic laboratory notebook as a second scientist reviewer.

Conduct qualitative and quantitative chemical analyses or experiments in laboratories for quality or process control or to develop new products or knowledge.

Maintain electronic laboratory notebook and compliance to GMP/GLP specifications.

Miantain laboratory instruments to ensure proper working order and troubleshoot malfunction when needed and performs other duties as assigned.

Preparation of analytical trend record for each products and Identifying the root cause for OOS results, product complains based on chemical analysis, and suggestions for corrective and preventive action (CAPA).

Merck Pharmaceutical-West Point, PA

Analytical Chemist II (09/2015-Current)

Perform analytical testing such assay, impurities, dissolution, content uniformity, and blend uniformity, physical testing of solid dosage forms.

Ability to work within multi-disciplinary teams to solve challenging problems within development projects as well as contributing with drug development team.

Using analytical techniques and instrumentation such as HPLC, UV, Dissolution, KF-Titration, pH Meter, Water activity and colorimeter.

Under the direction of a more senior staff member, carries out routine testing on Phase IIb/III pharmaceutical products.

Perform method validation and / or method development according to the different projects.

Interpreting data and adhering to strict guidelines on documentation when recording data.

Write technical papers or reports or prepare standards and specification for processes, facilities, products, or tests and review electronic laboratory notebook as a second scientist reviewer.

Conduct qualitative and quantitative chemical analyses or experiments in laboratories for quality or process control or to develop new products or knowledge.

Familiarity with statistical methodology such as DOEs

B. Braun Medical (CAPS) – Allentown, PA

Sterile compounding IV Tech (07/2015-09/2015)

Assists in the set up of the compounding room, equipments, and supplies for preparation of compounded sterile solutions, using aseptic technique.

Prepares compounded sterile products using aseptic technique.

Participates in clean room products introduction activities. Prepares records and monitors results for pharmaceutical quality assurance testing.

Use aseptic technique in the preparation of intravenous (IV) and compounded medications with strong mathematics skills.

Responsible for ensuring that all IV preparation and testing is completed following all standards for quality and timeliness (i.e. plans, organizes and schedules testing, ensures cGMP and SOP compliance, reviews data, meets specified timelines).

Support internal and external audits and inspections.

Cigna Healthcare -Horsham, PA

PTCB-Pharmacy Technician (08/2014-07/2015)

Fill prescription orders in an accurate manner that is compliant with state and federal regulations.

Maintain a positive, professional attitude when dealing with Cigna’s customers, employees and suppliers.

Operate and maintain Cigna’s dispensing equipment including: drug replenishment, preventative maintenance and cleaning with a high degree of accuracy.

Actively participate in pharmacy quality and process improvement initiatives.

Retrieve and interpret medication orders; perform pharmaceutical calculations.

Pharmerica Long Term Care (Part Time) – Hatfield, PA

Pharmacy Intern (11/2011– 07/2015)

Strong understanding of, and adherence to Pharmerica’s Standard Operating Procedures, answer inbound customer and physician calls in a professional, courteous and accurate manner in accordance with company standards.

Fill prescription orders in an accurate manner that is compliant with state and federal regulations.

Provide accurate and timely responses to customer requests submitted via Pharmerica’s CRM system.

Maintain a positive, professional attitude when dealing with Pharmerica’s customers, employees and suppliers.

Operate and maintain Pharmerica’s dispensing equipment including: drug replenishment, preventative maintenance and cleaning with a high degree of accuracy.

Use aseptic technique in the preparation of intravenous (IV) and compounded medications with strong mathematics skills.

Train and mentor new technicians

URL Pharmaceutical – Philadelphia, PA

Chemist (07/2011 – 10/2011)

Assisting the QC group with data analysis.

Responsible for ensuring that testing is completed following all standards for quality and timeliness (i.e. plans, organizes and schedules testing, ensures cGMP and SOP compliance, reviews data, meets specified timelines).

Management and review- Performing calculations to interpret data.

Working knowledge of a LIMS system (ideally Empower).

Utilizing empower to capture lab data.

Utilizing basic knowledge of HPLC, GC, Dissolution, UV, FT-IR, KF-Titrator, TLC, pH Meter, viscometer, colorimeter.

Millennium Pharmacy – Hatfield, PA

Pharmacy Technician (08/2008 – 01/2010)

Assist pharmacist in preparation dispense of medicine.

Receive information requests; research and provide information where appropriate; refer other inquiries to pharmacist.

Maintain patient records.

Retrieve and interpret medication orders; perform pharmaceutical calculations.

Dispensing of controlled drugs under supervision of pharmacist.

Sun Pharmaceutical Industries – Dadra, India

QC Officer-Scientist (06/2006 – 03/2008)

Analysis of finished products, in-process sample, Stability Study, process validation, cleaning validation, and cleaning verification sample.

Performed Analytical Testing on (HPLC, GC, UV, Dissolution, KF- Titrator, pH Meter, viscometer, and colorimeter).

Worked in a multi-disciplinary analytical laboratory environment in support of Product Development Projects, Calibrations and archiving chemical records.

Performed analytical testing such assay, impurities, dissolution, content uniformity, and blend uniformity, physical testing of solid dosage forms (tablets & capsules).

Preparation of analytical trend record for each finished products.

Identifying the root cause for OOS results, product complains based on chemical analysis, and suggestions for corrective and preventive action (CAPA).

Participate within process of auditing Complaint Records to ensure standard process is followed, data is consistent, and of high quality to assist with correct decision making.

Support internal and external audits and inspections.

Education

Bachelor of Pharmacy(Pharmaceutical Science), Amravati University, India Sep 2001 – Jul 2005

Bachelor of Pharmacy Honors, (Pharm-D) Nirma University, India, Sep 2009 – Jun 2010

Certification(s)

Certified Pharmacy Technician

Foreign Pharmacy Graduate Equivalency certified

Working towards getting certificate exam of Drug Safety Associate

Contact this candidate