Pramesh Kothari has over 25 years of experience in quality control and assurance for pharmaceutical companies, currently serving as Director of Quality Control at Nesher Pharmaceuticals where he oversees daily lab operations and compliance. Previous roles include General Manager of Quality Control at Cadila Healthcare where he managed multiple labs and 300 staff. He has a strong track record of successful FDA inspections and new product launches.

1. Pramesh Kothari 1650 Beale Street, MO, 63303 | pramesh_kothari@rediffmail.com |
314.220.2538
Summary of Qualifications
An eminently successful Quality Control professional with more than 25 years of comprehensive analytical, stability and
Microbiology expertise in complex formulations including Aerosol, Nasal, MDIs, DPIs, Injectable, solid-orals, transdermal in
Pharmaceutical industry. More than 7 years of experience as Director/General manager. Skilled in developing and enhancing
Quality Control standards, Compliance, Method Validations and Transfers, Stability and Timely releases. Adept at developing,
enhancing, monitoring sustained quality practices compliant with global compliance and global regulatory standards. Well-
versed in developing and enhancing Quality Control standards; with regulatory guidelines and its implementation. Competent
with conducting quality audits for on-site labs, contract labs, API, and formulation manufacturing. Adroit at managing multiple
labs and its functions. Skilled at developing new laboratories and compliance establishment. Able to cultivate strategic
relationships with employees, peers, managers, directors and stakeholders.
Core Competencies
| Quality Control | Stability | Microbiology | Quality Assurance | Laboratory QA Compliance | Auditing | KPIs | Quality Auditor-
Internal Audits | GLP | Method Validation | LIMS | TRACKWISE |LMS |Chromeleon (Thermo Fisher) / Empower HPLC Software
| OOS/ OOT/OOC Investigation| Deviation | Trending and Analytics | Root Cause Analysis and CAPA | ANDA Submission|
Instrument Qualification per 21 CFR part 11 compliance |Strategic/Analytical Thinking |Multitasking | Decision-Making |Team
Management | Complex Problem-Solving | Client Relation Management | Leadership | Project Oversight | Operational Support
| Communications | CAPEX And Budgeting | Regulatory Impact and Risk Assessments of Proposed Changes | Acting on CMC
Queries from Regulatory |Performing Gap Analyses to Enhance Quality Systems | Annual Product Quality Review | Technology
Transfers | Hiring | Mentoring | Composing Corporate Policies and Procedures for Laboratory|
Professional Experience
NESHER PHARMACEUTICALS, LLC., Bridgeton, MO
Director, Quality Control 09/2018 – Present
Directing the managers for daily operations of laboratory (Chemistry and Microbiology), stability and microbiology to maintain
high degree of performance, compliance and efficiency. Also, responsible for monitoring release targets. Define KPIs and
deliverables for continuous improvements. Overseeing and investigating OOS, OOT, deviations, Change controls, CAPA and
laboratory incidents. Responsible for overseeing the contract laboratory for testing requirements. Working with SME auditors
including LACHMAN for compliance improvements. Responsible for working with senior management for new project
initiation. Composing QC budget and overlooking resource management. Managing FDA audits and compliance of GMP and PAI
audits. Responsible for interviewing potential candidates and collaborating with HR for hiring QC professionals. Responsible
for timely launch of new products. Overseeing the training needs to develop skilled Quality workforce. Actively involved in
Quality Systems Development over site. Responsible for investigating FAR, Recalls and Market Complaint. Overseeing
upgradation of Laboratory instruments, Qualification, Maintenance and Calibration Program. Responsible for participating in
the business and compliance scheduled meetings. Designing more efficient processes to improve Quality and efficiency.
Actively involved in the meetings scheduled with the stakeholders for business development and discussing future aspects and
goals for the company.
Selected Achievement
 Successfully leading the Quality Control for two consecutive GMP and PAI FDA audits, resulted as VAI.
 Leading and collaborating with responsible stakeholders for the successful and timely launch Levorphanol Tablet.
CADILA HEALTHCARE (Zydus), LTD., India
General Manager, Quality Control 06/2015 – 09/2018
Directing 20 managers and more than 300 Quality Control professionals and managing 7 QC, Stability and Microbiology
laboratories. Responsible for developing the Quality culture by QUEST movement. Responsible for reviewing and approving
the documents including SOPs, OOS, OOT, OOC, Lab incidences, Change Controls, CAPAs and deviations. Work with SME
auditors like 5W, LACHMAN for compliance improvements. To support investigation team for hypothesis plan and root cause
analysis of OOS/OOT/OOC and laboratory incidences. Responsible for installing and maintaining CFR complaint instruments.
Accountable for upgrading quality system as per corporate guidance. Accountable to support mangers for trouble shooting in
case of any failures in the chemical testing. Responsible for achieving the release target and update the supply chain.
Responsible for monitoring and maintaining laboratory expenses per allotted budget. Responsible for timely
commercialization of ANDA products.

2. Pramesh Kothari P a g e | 2
Selected Achievement
 Successfully lead the Quality Control for three consecutive GMP and PAI FDA audits, resulted in zero observation after
warning letters.
 Awarded as best “Mentor” under QUEST movement.
 Leading successful customers audits like Blue point, Helm, Sagant.
 Successfully resolved analytical issues at European Facility and saved the products worth 2 million (USD),

Previous Experience
 Deputy General Manager, Quality Control (Central Method validation and Complex formulation analytical
laboratory), Sun Pharmaceuticals Industries Ltd. Vadodara, Gujarat India.
 Senior Manager- Deputy General Manager, Corporate Quality, Sun Pharmaceuticals Industries Ltd. Vadodara,
Gujarat India
 Senior Manager- Head Quality, Unimed Technologies (Group company of Sun Pharmaceuticals Ltd.) Baska, Gujarat
India.
 Senior Manager- Officer, Sun Pharmaceuticals Ltd. Halol, Gujarat India (Worked with Representatives of Eli Lily and
Co. for product development)
Education
 Master of Science, Chemistry – Madurai Kamraj University, Tamilnadu, India
 Bachelor of Science, Chemistry – Gujarat University, Gujarat, India