Shivangi Patel
** **** ********, ********* ******* ON M9W7E8 • 416-***-**** •
******************@*****.***
EXPERIENCE
• 2 years experience in pharmacy store as a pharmacist.
• Assist the Pharmacist with the preparation, packaging, and distribution of patient prescriptions
• Assisting with cashier responsibilities as required
• Managing documentations such as prescriptions, printing, invoices, etc.
• Prepare and implement SOPs of various functional sections
• Prepare calibration / STP'S / validation documentation (e.g., process validation, analytical method validation)
• Vendor qualification, vendor audit and maintain vendor documents as per various regulatory requirements
• Lead and manage external / internal customer and regulatory audits
• Handling of quality management system (e.g., deviations / change control / correction action and preventive action (CAPA) / out of specification (OOS) / failure investigations / annual product reviews)
• Coordinating the investigation of market complaints
• Review and approve QA controlled documentation
• Plan and organize annual training documentation with training coordinator on cGMP and technical aspects
• Management of quality control documentation as part of Quality Assurance follow-up (e.g, handling of control sample, review the investigation reports for incidents, out of calibrations, out of specifications, out of trends etc.)
• Projection of plan / QC instruments / equipment and its calibration, and validation schedule preparation
EMPLOYMENT HISTORY
QA Incharge Oct 2017 – Jan 2022
INFINIUM PHARMACHEM PVT LTD., Anand, Gujarat, India Pharmacist Apr 2015 – Oct 2017
Shiv Medical agency, Anand, Gujarat, India
Trainee Dec 2014 – Apr 2015
Accuprac Research labs PVT. LTD, Ahmedabad, Gujarat, India Trainee Mar 2013 – Aug 2013
Swiss Parenterals PVT. LTD., Ahmedabad, Gujarat, India EDUCATION HISTORY
M. Pharm (Quality Assurance) 2015
Gujarat Technological University, India
Thesis Project - “Development and validation of analytical methods for simultaneous estimation of Moxifloxacin HCl and Loteprednol etabonate in its bulk and pharmaceutical Dosage Form” B. Pharm 2013
Gujarat Technological University, India