Jyoti Kothari has over 24 years of experience in quality assurance roles in the pharmaceutical industry, including managing quality assurance as well as experience in validation, auditing, and ensuring compliance. She has a strong background in GMP requirements and regulatory submissions. Her experience includes roles managing quality assurance and serving as a compliance manager at various pharmaceutical companies.

1. Jyoti Kothari
India
jyoti.76.kothari@gmail.com +919427542062
linkedin.com/in/jyoti-kothari-38b7a9136
Summary
An eminently successful Quality Assurance professional with more than 24 years of diversified experience in
Quality Assurance, Manufacturing and Packaging in Pharmaceutical industry. More than 3 years of experience
leading the Quality Assurance as a manager. Skilled in conducting internal audits including the departments of
Manufacturing, Packaging, Quality Control and Quality Assurance and writing of audit reports. Skilled at preparing,
reviewing and ensuring that the QMS documents including Batch Manufacturing Records (BMRs), Batch Packing
Records (BPRs), Protocols (Process Validation, Process Characterization) and Change Controls are executed
as per GMP requirements. Adroit at execution of Equipment Qualification with GMP software. Competent in
managing the timely closures of CAPAs. Skilled in supporting Regulatory Audits, Customer Audits, SME Audits
and Corporate Quality Audits. Skilled at tracking and reviewing Market Complaint, Investigation Report and Global
CAPAs. Able to cultivate strategic relationships with employees, peers, managers, directors and stakeholders.
Core Competancies
Quality Assurance | QA Compliance | QMS | Auditing| Regulatory Impact and Risk Assessments of Proposed
Changes | Equipment Qualification | Cleaning Validation | Regulatory Inspection | Quality Metrics/ Trending |
Software skills including Documentum, TRACKWISE, LMS, ERP and SAP | Decision-Making | Problem-Solving
| Leadership| Regulatory Submission| Team Management | Client Relation Management | Project Oversight |
Operational Support | Identifying Changes in Regulatory Requirements | Technology Transfers | Mentoring |
Composing Corporate Policies and Procedures for QA
Experience
Validation Specialist
Nesher Pharmaceuticals (USA) LLC
Aug 2019 - Jun 2020 (11 months)
• Responsible for Cleaning validation, instrument and equipment qualification for Manufacturing,
Engineering, Quality Control, and Information Technology.
• Responsible for preparation of various documents as prerequisite of equipment qualification protocol
including GMP assessment, system, and component level impact assessment, 21 CFR part 11
assessment.
• Also responsible for Risk assessment of equipment. Involving in the discussions of protocols with
counterparts including Manufacturing, Engineering, Quality Control, Quality Assurance and Information
Technology for assessment concurrence and suggestions.
• Responsible for reviewing and approval of equipment qualification protocol and execution. Involved
and responsible for reviewing and investigating any deviations occurred during equipment qualification.
Responsible for preparing, reviewing and approval of master validation plan for ANDA product
submission. Responsible for preparation of periodic cleaning validation schedule, preparation of
cleaning validation protocols and summary report based on executed protocol.
• Responsible for monitoring of cleaning validation schedule.
• Accountable for reviewing and closing change controls in TrackWise.
• Also involved in the business and compliance scheduled meetings.
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2. • Accountable for designing more efficient processes to improve Quality and efficiency.
Compliance Manager
Zydus Group
Apr 2017 - Nov 2018 (1 year 8 months)
• Responsible for coordinating with regulatory agencies, customer, and corporate QA for audit planning.
• Co-ordinate with all departments of site for compliance as per cGMP and Regulatory Requirements.
• Prepare and submit compliance report for the regulatory, external SMEs and corporate audits.
• Get closure of commitments provided to regulatory and external agencies by regular meet with
respective department.
• Evaluate applicability of identified global CAPA for the site, assign responsibilities, target dates, track
and verify the implementation status.
• Suggest area of improvement in product quality and GMP/GLP enhancements at the site.
• Evaluate effectiveness of post CAPA implementation.
• Review and approve self-inspection planner and ensure audits as per schedule.
• Notifying the management on any observations that impacts product quality.
• Handling of change control and CAPA in TrackWise.
Deputy Manager Quality Assurance
Zydus Group
Aug 2015 - Apr 2017 (1 year 9 months)
Executive Corporate Quality
SUN PHARMA
Jan 2015 - Jul 2015 (7 months)
• Handling of Market Complaint
• Issuance of Corporate Guideline
• Issuance and closing of Global CAPA.
2. Tablet and Capsule department: (From 2008 to 2014)
• Preparation of new Master Batch Manufacturing record based on MF received from FDD for new
products.
• Review of Master Formula Card which is received from FDD.
• Preparation and review of risk assessment report based on MF as per regulatory guideline.
• Preparation and review of change control in accordance with the regulatory guidelines (Referring
guideline for changes like SUPAC IR/MR, EU variation, MCC for South Africa).
• Preparation and review of stability batch protocol, process characterization protocol, process validation
protocol in line with cGMP.
• Training imparted to concern supervisor and operator related to changes of batch manufacturing
record, process flow of process validation batches for ANDA product submission.
• Train the employees for the documentation activity like master batch manufacturing record
preparation, change control, protocols, ERP, metis.
• Follow up with various departments like QA / QC / Warehouse / FDD for the technical issues, CAR,
CC for further way out.
• Preparation of work order for first commercial batch and stability batches.
• Co-ordination with regulatory affairs for documents submission for ANDA product registration.
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3. • Well familiar with ERP system / metis for documentation, material management and it’s functionality.
3. Aerosol and Nasal spray department:
• Responsible for planning, execution, and monitoring of department as section head.
• Preparation and review of Master batch manufacturing record, master batch packing record, standard
operating procedure, change control, event -investigation.
• Responsible for ERP related work i.e. work order, Consumption order, Deviated issue order, material
return, stock availability etc.
• Manufacturing and packing of batches (Domestic as well as ANDA) as per procedure mentioned in
BMR and BPR respectively.
Executive
SUN PHARMA
Sep 1995 - Jan 2015 (19 years 5 months)
• Online documentation of batch manufacturing record, batch packing record, logbooks (Related to
manufacturing and packing activity including area temperature, relative humidity, differential pressure,
equipments).
• Maintained the area and perform activity as per GMP and regulatory requirement.
• Train the new supervisor and operators.
• Handling and monitoring of daily activities for manpower distribution and production planning.
• Preparation of qualification protocol and its execution of area and machines.
• Preparation of daily, weekly, and monthly report for productivity, machine utilization, product
launching, product problems, machine and area problems, material and manpower issues.
• Actively involved to find out root cause of manufacturing and packing related issue if any.
• Responsible for dispatches as per monthly requirement.
Packing Department: (Tablet/capsule packing, injectable product packing)
• Execution and monitoring of batch packing activity as per batch packing record.
• Follow the require GMP for packing activity. Like online filling of batch packing record, logbooks
(Related to packing activity i.e. area temperature, relative humidity, differential pressure, equipments).
• Preparation of change control attachment, master batch packing record.
• Preparation of Standard Operating Procedure related to departmental system, machines, and other
procedures.
• Train to operator and new officer for packing activity.
• Preparation of qualification protocols including packing equipment qualification. (Online labeling,
Online coding, Auto-racking).
• Handling of packing related issues.
• Daily and monthly planning of packing activity and preparation of daily, weekly, and monthly report.
Education
Tolani Institute Of Pharmacy - India
Associate's degree, Pharmacy
1992 - 1994
Licenses & Certifications
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4. Internal Auditor - Zydus Group
Certified GMP Trainer - Zydus Group
Six Sigma Yellow Belt - 6sigmastudy - The global certification body for six sigma
certifications
846731
Honors & Awards
FDA, MCC, MHRA, ANVISA, INVIMA, WHO - Audit
The quality audits were cleared under my leadership.
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