Resume

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 expertise incomplex
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 | Quality Assurance | Laboratory QA Compliance | Auditing | KPIs | Quality Auditor- Internal Audits
| GLP | Method Validation | LIMS | TRACKWISE | LMS | OOS/ OOT/OOC Investigation| 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 | Identifying Changes in Regulatory Requirements | Performing Gap Analyses to Enhance Quality Systems
| 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 and stability to maintain high degree of performance, compliance and
efficiency. Also, responsible for monitoring release targets and stability oversight. Overseeing and investigating OOS, OOT,
deviations, Change controls, CAPA and laboratory incidents. Working with SME auditors including LACHMAN for compliance
improvements. 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
participating in the business and compliance scheduled meetings. Designing more efficient processes to improve Quality and
efficiency.
Selected Achievement
 Successfully leading the Quality Control for two consecutive GMP and PAI FDA audits, resulted as VAI.
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 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.
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.

2. Pramesh Kothari P a g e | 2
Other 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
Education
 Master of Science, Chemistry – Madurai Kamraj University, Tamilnadu, India
 Bachelor of Science, Chemistry – Gujarat University, Gujarat, India
Other Information
 Legally eligible to work in US under L1-A Visa Status.