Hetalben P.
Senior Compliance Specialist
Experience
Nov 2023 - Present
2 years 1 monthSenior Compliance Specialist
Bristol Myers Squibb
- Responsible for writing, leading, and managing detailed investigations which includes conducting thorough assessments and determining the root causes of issues to prevent recurrence.
- Manage Corrective and Preventive Actions (CAPAs), create change controls, and initiate proactive measures to address potential compliance issues.
- Conduct risk assessments for the facility's pest control program & identify gaps and assist in developing comprehensive risk mitigation plans.
- Process documents through the Veeva Quality Management System (Infinity) according to site procedures.
May 2023 - Nov 2023
7 monthsQuality Assurance Specialist
Rocket Pharmaceuticals
- Support all regulatory filings and required reporting and review CMO batch records and assist in data verification.
- Responsible for or supporting key programs and functions such as annual product review, QC lab investigations & manufacturing investigations, change controls, tech transfer documents & associated data, batch record review, label management, product complaints, process improvement, cGMP training.
- Review drug substance, drug products and clinical trial material batch records.
- Review and approval of validation protocols (IQ/OQ/PQ).
- Manage and conduct internal audits, making recommendations for improvement.
- Coordinate with clinical operations and other departments involved in clinical trials to ensure that clinical objectives are met within the expected timeframe.
- Coordinate with other departments in creating, updating, and managing SOPs/work instructions.
- Prepare, format, and regulate the implementation of QA policies and standards.
- Assist with operations and local quality function in tracking, documenting, and reporting quality levels as well as other KPIs.
- Oversee corrective action process and platform, coordinating with other departments to identify root causes, corrections, measurements, and continual improvements.
- Create training materials and conduct training sessions as needed.
Aug 2022 - Apr 2023
9 monthsScientist
Experic
- Develop analytical method validation protocols and summary reports (Qualification, Validation, Verification and Transfer) to support transition to cGMP testing according to company SOPs, policies and regulatory guidelines.
- Perform and support analytical lab & R&D testing - execute testing, review data and documents for compliance and accuracy.
- Author technical documents such as analytical methods, Standard Operating Procedures, Qualification/Validation reports.
- Assist with deviation investigations, CAPA and change control.
- Perform general lab housekeeping, ordering and stocking supplies, and manage inventory for chemicals/reference standards.
Jan 2022 - Jul 2022
7 monthsDocumentation Specialist (Technical Writer)
Akorn Pharmaceuticals
- Author and review QC chemistry technical documentation such as specifications, test methods (ATM), monographs and Standard Operating Procedures as necessary.
- Represent QC chemistry as a member of the CAPA review board.
- Update QC chemistry documentation by initiating or reviewing Change Control Requests and Documentation Change Requests.
- Track CAPAs and perform actions as necessary to address CAPAs timely.
- Update Trackwise and/or Veeva with all necessary information and determine that CAPA is ready for approval.
- Coordinate with QA CAPA team to address comments and close CAPAs timely.
- Participate in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
- Use various computer software applications (Veeva, Trackwise) to complete assigned work activities.
- Manage technical documentation projects working directly with subject matter experts to gather information, create content, and obtain approvals using strong interpersonal and customer-service skills.
- Manage all aspects of service documentation administration and delivery, including change management and document control.
Jun 2021 - Dec 2021
7 monthsChemist III
Sun Pharmaceuticals
- Analyze finished products, stability, in-process material, raw materials, and validation samples according to assigned specifications, methods, and protocols.
- Audit and verify results including calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data.
- Write or update SOPs related to regulatory responsibilities and quality control of products and participate in systematic reviews to ensure accuracy and compliance.
- Write technical documents such as methods, specifications, method validation protocols and reports, method transfer protocols and reports based on corporate policies, SOPs, compendia, ICH and FDA guidance.
- Generate change requests for analytical documents and route documents for review and approval; maintain hard copies and electronic files of technical documents.
- Perform and author laboratory Lab Event/Out-of-Specification and Out-of-Trend investigations and close them timely.
- Perform root cause analysis using various investigation tools and develop appropriate CAPAs.
- Conduct gap assessments with laboratory SOP and global documents.
- Conduct unplanned deviation investigations, impact assessments and appropriate CAPAs.
- Initiate and support deviations, investigations, and corrective/preventive actions to drive resolution and close site-level compliance gaps.
- Investigate facilities department deviations to determine root cause and necessary CAPAs working cross-functionally with manufacturing operations, supply chain, quality, and engineering.
- Complete all assigned corporate, facilities, GMP and EHS training within required due dates.
- Review deviations, CAPA, and non-scheduled work orders to detect repeat issues and identify solutions to prevent further occurrences.
Feb 2018 - May 2021
3 years 4 monthsChemist I & II
Integra Life Sciences
- Perform tests and analysis of raw materials, bulk and finished products, scale-up samples, process validation samples, cleaning validation samples, and stability samples using instrumentation such as HPLC, UPLC, GC, UV-Vis, FTIR.
- Conduct laboratory testing and general laboratory maintenance, including in-process and final product release testing and stability testing.
- Assist in developing and qualifying/validating analytical methods without supervision.
- Review and verify analytical data and reports, ensuring accuracy and consistency.
- Submit samples for shipment to third party labs when necessary.
- Maintain GMP/GLP laboratory notebooks and relevant documentation.
- Maintain laboratory instrumentation required for testing.
- Assist with laboratory Out-of-Specification (OOS) investigations and summarize information and trends in investigation reports.
- Assist in investigation of non-conformance and implementation of corrective and preventative actions.
- Complete data entry for trending reports for in-process and finished goods quality control testing and stability testing.
- Evaluate laboratory safety procedures to ensure compliance or improvements as needed.
- Train team members in the analytical department as assigned.
- Dispose of hazardous waste according to environmental regulations and company procedures.
- Perform upstream and downstream water sample testing and handle biohazard material in compliance with OSHA and SOPs.
- Test raw materials as per USP regulations and verify calibration of equipment, correct preparation of reagents and solutions, and accuracy of associated calculations.
Jan 2016 - Mar 2017
1 year 3 monthsQuality Control
Preferred Display, Inc.
- Document inspection results by completing reports and logs; summarize re-work and waste; input data into quality database.
- Work on the manufacturing floor of a custom display manufacturer.
- Approve incoming materials by confirming specifications; conduct visual and measurement tests; reject and return unacceptable materials.
- Approve in-process production by confirming specifications; conduct visual and measurement tests; communicate required adjustments to production supervisor.
- Approve finished products by confirming specifications; conduct visual and measurement tests; return products for re-work and confirm re-work.
- Keep measurement equipment operating by following operating instructions; call for repairs.
Nov 2013 - Nov 2015
2 years 1 monthIndia
QC Chemist
Bhagwati Medicare Devices
- Organize lab test solutions, compounds, and reagents.
- Calibrate and maintain laboratory instruments and determine equipment operating efficiency.
- Interpret and maintain test results and serve as the department lab quality assurance officer.
- Operate and maintain analytical instruments such as UV spectrophotometer, ETO gas sterilizer, BOD incubator, laminar airflow, single pan balance, lab incubator, autoclave, pH meter.
Jun 2011 - May 2013
2 yearsIndia
Chemistry Teacher
Shivam Vidyalaya
- Perform job as a chemistry lecturer and laboratory teacher.
- Perform quantitative and qualitative analysis of organic and inorganic mixtures.
- Perform acid-base and redox titrations.
- Conduct experiments like HPLC, GC, TLC for separation of mixtures.
- Operate instruments like pH meter, viscometer, conductometer, UV spectrophotometer.
Jun 2009 - May 2011
2 yearsIndia
Chemistry Teacher
School of Achiever
- Perform job as a chemistry lecturer and laboratory teacher.
- Perform quantitative and qualitative analysis of organic and inorganic mixtures.
- Perform acid-base and redox titrations.
- Conduct experiments like HPLC, GC, TLC for separation of mixtures.
- Operate instruments like pH meter, viscometer, conductometer, UV spectrophotometer.
Summary
Result driven & ambitious Pharmaceutical/Medical device/Bio tech consultant with expertise in quality and Regulatory compliance seeking a challenging role where I can utilize my skills, adaptability, and strong work ethic to achieve company’s goal for growth and success.
Languages
English
AdvancedGujarati
AdvancedHindi
AdvancedEducation
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Bachelor of Education · Science & Mathematics
Gujarat University
Bachelor of Science · Chemistry · India
Gujarat University
Master of Science · Organic Chemistry · India
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