Strongly reliable and focused Quality / Regulatory Affairs professional with knowledge of quality management system, document compliance, GAP assessment against regulatory authorities and regulatory process of drugs, biologics and medical devices. Great multitasker able to handle multiple projects efficiently and accurately with data entry, technical writing and strong communication skills.
Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices June 2017
NORTHEASTERN UNIVERSITY – Boston, MA
Masters of Pharmaceutical Technology May 2013
GUJARAT TECHNOLOGICAL UNIVERSITY -- Ahmedabad, INDIA
Bachelors of Pharmacy April 2011
SARDAR PATEL UNIVERSITY – Anand, INDIA
RELEVANT WORK EXPERIENCE:
Quality Control Analyst I November 2017-December 2018
THE FOUNTAIN GROUP (Employee assigned to Takeda pharmaceuticals – Cambridge, MA)
Vendor Management Support
•Tracking and requesting vendor quotes, managing invoice approvals
•Managing external reference standard storage site and supporting RS inventory management
•Coordinating test sample shipments from manufacturing to testing sites.
Assessing temperature excursions and issue memos to support product use
Conducting reference standard (RS) performance monitoring (Data entry, trending, make trend charts)
Interpreting data with support from supervisor, and contribute to technical reports and regulatory filings
Conducting data review process for the data from offsite test labs and organize in QC servers
Initiating workflows for protocol and report uploads/approvals in relevant electronic documentation systems
Build study/tests and enter GMP data in validated data repository
Intern April 2017-June 2017
NUTRIMEDY – Boston, MA
Created internal reporting mechanisms as part of a standard of conduct and other applicable documents.
Responsible for data entry for the data evaluation to CDC Diabetes Prevention Recognition Program (DPRP). Good working knowledge of HIPAA
Created good documentation practices document and proper mechanisms of submitting HIPAA compliant data to the CDC for DPRP
Quality Analyst Feb 2014-July 2015
MEDUSIND SOLUTIONS – Ahmedabad, INDIA
Helped users to understand the review and document revision process.
Responsible for reviewing document change requests and initiating work flow in EDMS system by assigning approved reviewers to create control documents like SOPs, protocols, policies, specifications and training slide decks to facilitate technical writing services.
Reviewed and approved documents before mastering and distribution to make sure correct format, templet, page numbers, scan copies, document number, attachments, content alignment and approver e-signature to ensure GDP compliance at site
Assisted in trouble shooting of work flow initiated to create control documents
Supported offshore Quality risk assessment documents for EU, Japan and China for inspection readiness and updated internal auditor certified list to remain up to date to ensure timely completion of internal audits.
Drafted, changed and updated the audit checklist based on GAP assessment, Risk assessment and previous audit observations.
Responsible for presenting quality metrics, quality system, training compliance report for the department on monthly basis to present in interdepartmental meeting.
Responsible for running biweekly report on all running work flows and work flow owners to rectify any associated issues
Familiar with schedule requalification trigger, forced training assignment, interlinking of EDMA and LMS system by providing effective document links
Responsible for timely reporting and submission of the information.
Quality Intern May 2010--Jun 2011
RELISH PHARMACEUTICALS – Ahmedabad, INDIA
Worked in the R&D and production department
Gained training in HPLC and assisted in drafting technical QC result comparison.
Quality evaluation, Sop compliance and shop floor compliance.
Gained training on the manufacturing plant
Observed operations to gain training in Tablets, Capsules, Liquid orals and Injectable section
New drug development and regulatory submission (3 Months)
Created Investigational product labelling, Clinical Protocol, Informed Consent document, Pre-IND meeting request and Investigational New Drug (IND) Application for the FDA approved product.
Developed skills of a reviewer from the Institutional Review Board by reviewing different Clinical protocols and Informed consent documents.
Formulation and Evaluation of Colon Targeted Tablet of Mebendazole (6 Months)
This research study was to explore the feasibility of combine approach of pH and time dependent colon targeted drug delivery system of Mebendazole.
Estimation of Simvastatin and Niacin in their combined Pharmaceutical dosage form by Derivative Spectroscopic Method (6 months)
This research study was to develop a Derivative spectroscopic method on the drug product containing Simvastatin and Niacin.
Poster Presentation at Indian Pharmaceutical Conference in Dec-2010 at Manipal University
Good technical writing skills
Practical knowledge of the Traditional 510(k) premarket submission and technical writing
Deep knowledge of US regulations and international and global authorities (EMEA, ROW and WHO, ASPAC, LATAM, METERA, etc.) and applicable international regulations and standards (CFR, ICH, MDD, IVDD, QSR, ISO 13485, CMDCAS, etc.)
Brief understanding regulatory submissions including IND, NDA, ANDA and BLA filing along with Premarket approvals (PMA), 510k submission and HDE for medical devices.
Familiar with 21 CFR, cGMP, GCP, GLP, Quality management system (QMS), Standard operating procedure (SOP) and ICH guidelines along with eCTD format specifications.
Good fundamental understanding of CAPA, deviation, change control, root cause analysis, and Quality System Regulations, such as 21 CFR 820, 21 CFR 803, and ISO13485
Understanding of the FDA meeting requests, conduct of the Clinical trials, commercialization and Post Market surveillance.
Windows Operating Systems and Application Software like Microsoft Office Package (MS Word, Excel, and PowerPoint) and Adobe acrobat skills.
Strong communication skills, learning and organizing skills with the ability to manage time, work and people effectively, Excellent organizational, problem-solving, and analytical and time management skills.
Qualified Distance Learning – General Course on Intellectual Property - 2 by World Intellectual Property Organization in May-2012.