Career Objective

To pursue the knowledge, that can strengthen and sharpen my technical skill and make me proficient for acclimatize the global challenges in this industry and to become an asset to your organization.

Academic Qualification

Sr. No.

Degree

Passing Year

Institution

Subject

Grade

1

M.Sc.

April-2015

Madurai Kamaraj

Chemistry

Second class

2

B.Sc.

April-1993

Gujarat University

Chemistry

Second class

Computer Literacy

Basic Computer knowledge.

Operating System

:

SAP [ System Application Product Q.M.S Module

Application

:

Microsoft Word, Excel, PowerPoint & Internet

Professional Experiences

At present working in Lincoln pharma 22.9.2023 Assistant MANAGER-Q.C

PRESENT COMPANY:

PERIOD

POSITION

WORK RESPONSIBILITIES

MERRIL PHARMA PVT LTD, BAVALA

10.09.2022

to 15.9.2023

Manager -Quality Control

Leading the Under-Designees/ On-Job Training & Coaching

SPEC -MOA

SOP Preparation & Review

Document Review

Water validation and Testing

Working Standard Preparation

RM-PM Testing

Finished Product Testing

PRESENT COMPANY:

PERIOD

POSITION

WORK RESPONSIBILITIES

UMAVIDA PHARMA PVT LTD., Kadi

15.07.2021 to 01.09.2022

Manager -Quality Control

Leading the Under-Designees/ On-Job Training & Coaching

SPEC -MOA

SOP Preparation & Review

Document Review

Water validation and Testing

Working Standard Preparation

RM-PM Testing

Finished Product Testing

PREVIOUS COMPANY:

PERIOD

POSITION

WORK RESPONSIBILITIES

SAKAR HEALTHCARE LIMITED, Changodar, Ahmadabad

September 2016 to July 2021

Manager -Quality Control

Audit functions such customer/regulatory audits, Self-inspection, External audits of suppliers that resulted in 4 successful and back-to-back ISO audits on medical device and cosmetics as well as FDA and Health Canada during 2nd month of employment.

Determined, negotiated and agreed on in-house quality procedures, standards and specifications leading to updated and more compliant quality SOPs and specifications.

Reviewed, revised and approved Annual Product Quality Reports resulting to more robust, concise and compliant reports acceptable to FDA during its visit.

Assessed customer requirements and ensured that these are met leading to numerous successful collaborations with the clients. Specified quality requirements of raw materials with suppliers resulting to acquiring more qualified vendors for raw materials. Investigated and set standards for quality and health and safety that ensured all customer complaints and production deviations are fully completed and approved.

Ensured that manufacturing processes comply with standards at national and international level leading to successful project launches and new projects that were started in production in a timely manner.

PRESENT COMPANY:

PERIOD

POSITION

WORK RESPONSIBILITIES

DISHMAN PHARMACEUTICALS & CHEMICALS LTD. Bavla,

August 2015 to August 2016

Manager -Quality Control

Worked with operating staff to establish procedures, standards, systems and procedures resulting to fewer production non-conformances.

Wrote management and technical reports and customers’ charters that clarified and addressed all client and customer concerns resulting to more positive feedback.

Determined training needs that ensured better compliance to procedures.

Troubleshoot and run instruments such as HPLC.

Directed objectives to maximize profitability that were well received and being executed currently by the QC Department. Monitored performance and supervised technical or laboratory staff.

PREVIOUS COMPANY:

PERIOD

POSITION

WORK RESPONSIBILITIES

NIRMA LIMITED.

February 2011 to July 2015

Quality Control Sr. Executive

Worked with operating staff to establish procedures, standards, systems and procedures resulting to fewer production non-conformances.

Wrote management and technical reports and customers’ charters that clarified and addressed all client and customer concerns resulting to more positive feedback.

Determined training needs that ensured better compliance to procedures.

Troubleshoot and run instruments such as HPLC.

Directed objectives to maximize profitability that were well received and being executed currently by the QC Department.

Monitored performance and supervised technical or laboratory staff.

PREVIOUS COMPANY:

PERIOD

POSITION

CLARIS LIFE SERVICES

December 2004- February 2011

Quality Control Sr. Executive

Worked with operating staff to establish procedures, standards, systems and procedures

resulting to fewer production non-conformances

Wrote management and technical reports and customers’ charters that clarified and addressed all clients’ and customers’ concern resulting to more positive feedback

Determined training needs that ensured better compliance to procedures

Troubleshoot and run instruments such as HPLC

Directed objectives to maximize profitability that were well received and being executed currently by the QC Department

Monitored performance and supervised technical or laboratory staff

PREVIOUS COMPANY:

PERIOD

POSITION

BRUSSELS LAB PVT LTD.

February 2000 to December 2004

Quality Control In-Charge

Authored key control procedures relating to GMP requirements for document control that led to more efficient Micro. quality system

Total Work Experience : 22+ Years in Pharmaceutical Industries

Job Profile

Knowledge of operating various HPLC systems of Shimadzu, Dionex and waters.

Knowledge of handling various sophisticated lab instrument like Gas chromatography, UV spectrophotometer, FTIR, Polarimeter, Malvern Particle Size Analyzer, TOC Analyzer, Melting point Apparatus, Karl Fisher, Tap density tester etc.

I know various chemical & instrumental analysis of in process analysis, raw materials, finished products, process validation, cleaning validation, stability analysis, technology transfer etc.

Having adequate knowledge related cGMP.

Having knowledge related to reference standard and working standard.

Documentation of Q. C. department.

Preparation of SOP, Specification and Method of analysis.

Review of Raw material, Intermediate, Finish product and working standard protocol. Also review of Instrument calibration records, Specification, Method of analysis and SOP document. Approved vendor Qualification for Raw material.

Handling of all type of QC functions as well as Audit preparations for USFDA, EU, WHO, ISO

Instrument Knowledge

H.P.L.C.

G.C.

F.T I.R.

U.V. Spectrophotometer

Particle Size Analyzer

Polarimeter

K.F. Apparatus

Melting Point

TOC Analyzer

Tap density tester

Auto-titrator

UPLC

DECLARATION

I hereby declare that the above mentioned and stated details of me and my profession are very true to the best of my knowledge.

REFERENCES:

Available upon request

Place: Ahmedabad. Submitted by:

Date: SUKETU. C. DESAI

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