Summary
Overview
Work History
Education
Skills
Accomplishments
Publications
References
To work on new projects
Timeline
Generic

BHAUMIK SUKHADIA

Jersey City,NJ

Summary

Quality-driven Compliance Analyst familiar with tracking, documentation and reporting requirements. Assesses work, materials and procedures and recommends adjustments to maintain compliance. 12 Years of experience and motivated, energetic mindset. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

Overview

12
12
years of professional experience

Work History

Sr. Compliance Analyst, Quality Control

Avet Pharmaceuticals Labs Inc.
11.2019 - Current
  • Collaborates with Laboratory Head to develop, implement and update changes as per regulatory requirements by overseeing laboratory compliance program which includes but not limited to continuous updates in training system, instrument management system with respect to QC Compliance system
  • Provide technical project leadership, participating in protocol development and execution for test method development, validation/verification, and related activities
  • Provide expert level troubleshooting of laboratory equipment, methods, and procedures
  • Monitor and recommend continuous improvement in the Quality Control systems and practices to in line with cGMP regulations and Regulatory expectations
  • Provide support in creation of Microsoft-based excel calculation templates according to 21 CFR Part 11 and Waters Empower 3 software auto calculation verifications
  • Conduct training to all level employees on FDA readiness, data integrity, Quality compliance, operation of new software, instruments, and good documentation practice
  • Assist to prepare and review FDA Readiness guideline for the company to get prepared for future FDA inspection
  • Ensure all qualification activities are conducted in compliance with cGMP, company policies, protocols, safety standards and applicable SOPs
  • Perform lab audit and inter-department audit to verify different FDA inspection related aspects followed by audit report that aligns with cGMP expectation
  • Management of laboratory change controls through Track wise software and monitor, measure and control the related process improvements
  • Superintending result recording of completed testing of finished product, raw materials, stability COAs, creation of specifications with utilization of SAP-Quality Module transactions
  • Work in partnership with all departments to develop compliance procedures for cGMP activities
  • Recommend to change existing process, system, equipment
  • Prepare new documents as per current USP, FDA, ICH guidelines for pharmaceutical drug substance and products, such as creation and revision of specifications, qualification reports, validation reports
  • Revise and update SOPs, Quality Control Methods (QCMs), specifications, protocols, policy, technical reports as needed
  • Review of Compendia and perform assessment on changes to be implemented
  • Perform Operational Performance Qualification (OPQ) of laboratory instrument software
  • Oversees Method Validation of Active Pharmaceuticals Ingredients for particle size by Malvern Mastersizer 3000
  • Develops or implements policies, or procedures to ensure regulatory compliance
  • Conduct and oversee laboratory events, deviations and non-compliance investigation reports pertaining to analytical experiments to identify root cause, product impact and corrective/preventative actions (CAPAs) for Quality Control department in support of compliance improvement
  • Perform theoretical risk assessment based on potency score calculation as per chemical structure for presence of N-nitrosamine impurities in raw materials, excipient and finished products
  • Implementation of business-related decisions and strategic planning after management approval for better productivity with minimal cost.

Chemist-I, Quality Control

Heritage Pharma Labs Inc.
10.2013 - 10.2019
  • Reviewed USP, EP compendia and performed assessment on changes to be implemented on timely basis
  • Performed testing of residual solvents, limit tests and related compounds in raw materials for release by using Gas Chromatography
  • Performed water activity of finished product to measure moisture content by TDL water activity meter
  • Maintained laboratory instrument inventory control by using Track pro software
  • Performed Raw Material/Finished Product Release/Stability/R&D testing (Physical testing such as Weight Variation, Hardness, Thickness, Friability, Disintegration, Moisture Analysis by KF titrator /Loss on Drying/Measurement of pH/Conductivity, Bulk and Tap Density testing) under cGMP guidelines
  • Analyzed finished products to determine dissolution, composition, purity, and chemical content
  • Performed limit test using Fluorescence Spectrophotometer RF-6000 by extraction method
  • Performed sampling of microbial bioburden for finished products
  • Compiled and interpreted results of tests and analysis in the validation reports and Certificate of Analysis
  • Maintained inventory of reference standards, chemicals and columns used in daily testing for laboratory
  • Performed Calibration of Laboratory equipments used for routine physical and analytical testing
  • Maintained Laboratory documentation with details of test procedures, raw data, and results in accordance with Regulatory Guidelines.

Technical Writer, Quality Control

Emcure Pharmaceuticals USA Inc.
10.2012 - 10.2013
  • To edit, rewrite, or otherwise prepare documentation on new product development, quality control reporting, procedures, and R&D projects with troubleshooting reports by making corrections as required
  • Interacted with AR&D department to prepare and finalize the SOPs and analytical methods
  • Prepared analytical documents such as API (Active Pharmaceutical Ingredient), IP (In process) and FP (Finished Product) specifications, method validation protocols, reports, stability testing data reports and particle size reports
  • Managed the documentation required for any changes as per functional requirements for change control, procedure updates, analytical method.

Education

Master of Business Administration (MBA) in Healthcare Management -

Goldey Beacom College (GBC)
Wilmington, DE
05.2026

Master of Science (M.S.) in Pharmaceutical & Medicinal Chemistry -

New Jersey Institute of Technology (NJIT)
Newark, NJ
05.2012

Bachelor of Pharmacy (B. PHARM) -

L. B. Rao Institute of Pharmaceutical Education & Research, Gujarat University
Gujarat, India
04.2009

Skills

  • Lab solutions software
  • UV Probe software
  • Empower 3 software
  • SAP software
  • Trackwise software
  • Track Pro software
  • Ti-Amo software
  • Microsoft Office
  • Leadership
  • Project Management
  • CGMP and cGLP Audit of internal departments
  • Problem solving
  • Verbal and written communication
  • Troubleshooting
  • Training for compliance and safety awareness
  • Compliance Monitoring
  • Documentation skills
  • Reporting skills
  • Internal Auditing
  • Investigations expertise
  • Teamwork and Collaboration
  • Time Management
  • Attention to Detail
  • Multitasking
  • Problem-solving abilities
  • Reliability
  • Critical Thinking
  • Organizational Skills
  • Effective Communication
  • PowerPoint Presentations
  • Compliance Training
  • SOP Development
  • Audit management
  • Interpersonal Skills

Accomplishments

  • Ranked 29th at All India Level in National Level Pharmacy Talent Search Examination (NLPTSE) '2008, (senior level), Pharma Helpline Society, Rajasthan, India.
  • Member of Pharma Helpline Society, Rajasthan, India & Inpharm Association, Bangalore, India.
  • Poster & Model presentation on Liquid Chromatography-Mass Spectroscopy (LC-MS) in Pharmafest '09, Parul Institute of Pharmacy & Baroda College of Pharmacy, Gujarat, India.

Publications

  • Published a Research paper on “Formulation & In-vitro Dissolution Study of Metformin Solid Dispersions” in the 7th Annual Graduate Research Day ’2011, GSA, NJIT, Newark, USA.
  • Published a Research paper on “Formulation & In-vitro Dissolution Study of Metformin Solid Dispersions” in the 2nd IAPST (International Association of Pharmaceutical Scientists & Technologists) at Annual National Convention ’2008, College of Pharmacy, Madras Medical College, Chennai, INDIA.

References

Available upon Request

To work on new projects

I love to work on new things rather than doing the same thing everyday.

Timeline

Sr. Compliance Analyst, Quality Control

Avet Pharmaceuticals Labs Inc.
11.2019 - Current

Chemist-I, Quality Control

Heritage Pharma Labs Inc.
10.2013 - 10.2019

Technical Writer, Quality Control

Emcure Pharmaceuticals USA Inc.
10.2012 - 10.2013

Master of Business Administration (MBA) in Healthcare Management -

Goldey Beacom College (GBC)

Master of Science (M.S.) in Pharmaceutical & Medicinal Chemistry -

New Jersey Institute of Technology (NJIT)

Bachelor of Pharmacy (B. PHARM) -

L. B. Rao Institute of Pharmaceutical Education & Research, Gujarat University

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