Shivangi Patel

Over 8 years of pharmaceutical analytical experience in Analytical Development and Quality Control departments in ANI Pharmaceuticals, formerly called as Novitium Pharma LLC as a Senior Chemist, which is approved by FDA and located in East Windsor, New Jersey. Expertise in developing methods rapidly using GC with advanced technology and software, designing and executing validations for successfully developed methods with advanced statistical tools involved Quality control as per USP and FDA requirements. Knowledge in GMP and GLP environment following ICH guidelines.

Proficient handling of advanced analytical equipment with knowledge in cGMP, EP, MHRA, and USFDA regulatory bodies.

Senior Chemist - Novitium Pharma LLC, USA - East Windsor, New Jersey

(2020-11)

Analytical Research & Development

• Analytical Method development and Validation
• Validation of analytical methods as per ICH guidelines
• Preparation of Validation Protocols, Reports and Summary reports
• Verify Data integrity activities in the Laboratory
• Planning and monitoring routine analytical work
• Supporting product development by analyzing residual solvents, Dissolution profiles, samples from pre formulation studies
• Optimization studies and accelerated stability studies
• Preparation of specification and standard testing procedure
• Handling of change control and deviations
• Analytical Method verification of Pharmacopeial as well as vendor methods
• Method Equivalency study between compendial and non-compendial methods
• Performing analytical method development and validation by GC Techniques
• Testing & Analysis in-vitro bioequivalent studies like Potentiometric Titration and Water Content analysis
• In Quality control, supporting API testing, Cleaning Validation and verification and Global stability analysis for all Commercial and ANDA samples

QA Reviewer - Apothecon pharmaceutical Pvt Ltd - Gujarat

(2017-01 - 2019-09)

Quality Assurance

• Prepared and Reviewed the SOPs (Standard Operating Procedures)
• Reviewed Change Control and Deviations/OOS
• Prepared Audit compliance report/response
• Prepared and Reviewed APQR (Annual Product Quality Review)
• Prepared and reviewed various qualification protocols and reports
• Reviewed & Draft specifications, Methods of analysis, BMR for product formulation & substance API
• Assisted regulatory team for documentation part for regulatory submission
• Reviewed the executed BMR, cleaning record and associated deviations before batch release
• Reviewed Quality control Documents
• Reviewed BMR, BPR, BCR and Logbook of online Manufacturing Process
• Involved in product(s) change control, CAPA, Finished Goods Complaint handling, Market analysis
• Developed & written Instructions for CAPA reports
• Developed and maintain manufacturing Procedures & documentations
• Assist & implement all regulatory (QSR, FDA, cGMP, QSR, ISO) Compliance and Training personnel
• Manufacturing documentations, specifications and technical reports
• Manufacturing support to day-to-day production line
• Support Regulatory Compliance & Standards and Incoming inspections
• Review & understand Validation Process & data analysis Reports
• Support to production lines and QA/QC validation process and all level testing
• Support & assist to all level operations, Supplier Qualification
• Interface with Manufacturing, Suppliers, Documents Control
• Maintained & documents per Regulatory Compliance & Standard, Quality System, ISO

M.Pharm - Quality Assurance - Babaria Institute of Pharmacy (2014-09)

B.Pharm - Shree Swaminarayan Pharmacy collage (2010-08)

HSC - New Haven Vidyalaya (2010-03)

SSLC - New Haven Vidyalaya (2008-04)