1. CURRICULAM VITAE
Mukesh Kumar Tiwari
Quality Assurance
Alkem Laboratories, Limited
Daman & Diu [UT]
Email address: mtiwaripharma@rediffmail.com Phone no: (M) 91-7698505184
OBJECTIVE:
To make in-roads in an organization that gives me scope and wide spread opportunities to
apply my knowledge and skill, spearheading the task that has been assigned with undivided
devotion & dedication leaving no stone unturned the pinnacle glory of the esteemed
organization.
EMPLOYMENT HISTORY:
Alkem Lab. Limited
From Jul01, 2016 o till date , Designation: Asst.Manager
Currently handling to QMS such as Deviation, change control. OOS, CAPA, incident and
market complaint in Solid oral as well as sterile.
USV LIMITED:
Diversified & integrated pharmaceutical manufacturing company. Company infrastructure
includes; Formulation Research & Development for API & Formulations. Facilities for Sterile
& Non-sterile Formulations. Other manufacturing includes synthetic & non synthetic API
manufacturing facilities. Dedicated solid oral & injectable dosage formulation facility is well
equipped with upgraded technology. Currently supplies to US, EU, Canada & ROW region
Designation: Sr. Executive - Quality Assurance
Accreditations: MHRA, USFDA, MCC and WHO.
DURATION: From Jun 2011 to Jun30, 2016 [5 + Year]
PLETHICO PHARMA LIMITED:
Leading Indian based pharmaceutical company. This facility includes dedicated facilities to
manufacture cephalosporin, Beta-lactam general category products of Sterile & solid oral
Dosage Forms. Sterile dosage forms include dry powder and Solid oral dosage forms
include tablets, capsules and dry powder suspensions. Currently supplies to India, & ROW
region.
Designation: Sr. Officer - QC / Microbiology (From Nov’2009 to May’2011).
Accreditations: MHRA / MCC / WHO-GENEVA / ANVISA / TGA approved formulation units.
1

2. Ipca Laboratories Limited:
For more than 60 years, Ipca has been partnering healthcare globally in over 110 countries
and in markets as diverse as Africa, Asia, Australia, Europe and the US.
Ipca is a fully-integrated Indian pharmaceutical company manufacturing over 350
formulations and 80 APIs for various therapeutic segments.
These are produced right from the basic stage at manufacturing facilities endorsed by the
world's most discerning drug regulatory authorities like US-FDA, UK-MHRA, EDQM-Europe,
WHO-Geneva and many more.
Ipca is a therapy leader in India for anti-malarial with a market-share of over
34% with a fast expanding presence in the international market as well. We also lead in
DMARDs (Disease Modifying Anti-Rheumatic Drugs) treatment for rheumatoid arthritis. We
have leading brands in 5 therapeutic areas, with 4 of our branded formulations being ranked
among the Top-300 Indian brands by ORG-IMS.
Designation: Jr. Officer – Documentation / Quality control (Nov 2009 to Oct 2010)
Accreditations: MHRA, MCC, ANVISA, WHO etc.
DURATION: Apr, 2007 to Oct, 2008 and Oct, 2008 to Oct, 2009
SUMMARY OF RESPONSIBILITIES:
1. Quality Managment system:
• Preparation and review of Standard operating procedure.
• Prepreation and review of product quality reviews with statistatical
representaion.
• Handling of Change managment systems (Manual).
• Handing of effective Deviation managment with root cause analysis using
techniques like Ishikawa technique, Go and See etc.
• Identification, tracking and implementation of corrective action to avoid re-
occurance and preventive action to avoid occurance.
• Preparation and exceution of Risk assesment protocols and mitigation plans
• Review of BMR, BPR, MFR process validation and cleaning validation
documents.
2. Validations and Qualifications:
• Handling of the Validation master plan for site / Site Master File.
• Handling of aseptic process simulation for Liquid/dry powder injectable
inclusive for prepareation of protocol/planning invervention/exceution and
summary report.
• Prepration and handling of enviromental monitoring plans for solid orals and
sterile injectable section as per regulatory guidance
• Preparation of the temperature mapping study based on sesonal variations.
2

3. 3. Instruments Equipments and sowftare well versed:
• Instruments/Equipments:
TOC, Incubator and Luxmeter.
• Sowftare
Windows 7, Microsoft office, SAP and LIMS.
4. Co-ordination with cross-functional department :
• External:
Cordination with RA Department for effective preparation of protocols and with
regulatory for timely submission of documents for preparation of dossier
• Internal:
Cordination with production,Quality control, Process development laboratory and
engineering, warehouse for timely exceution and completion of activity
5. Audits:
i. I have participated with the auditee team of the company during the regulatory
audits from:
• USFDA
• TGA
• MHRA
• ANVISA
• MCC
• WHO (Geneva)
• NAFDAC
• WHO (India)
6. Training :
• Validation –Getting the basics right by Mr. Atul Shirgavkar
• Root cause analysis and corrective and preventive actions by SSA Business
solution (P) Limited
3

4. PERSONAL PROFILE:
EDUCATIONAL PROFILE:
My Strong Point
I have a never-ending thirst to learn and explore the intricacies of new concepts. Possessing
good communication and interpersonal skills would take up assignments with enthusiasm,
playing a positive role in the team and an ability to learn quickly and adapt to any
environment.
PERSONAL DETAILS:
NAME : Mr. MUKESH KUMAR TIWARI
FATHER’S NAME : MR. JAGRAM TIWARI
DATE OF BIRTH : 15TH APRIL 1981
MARITAL STATUS : MARRIED
EDUCATIONAL QUALIFICATION : MASTER IN SCIENCE (BIOTECHNOLOGY)
LANGUAGE KNOWN : ENGLISH AND HINDI
TOTAL EXPERIENCE : 10.6 YEAR
I hereby declare that the above information is true to the best of my knowledge and belief.
PLACE: DAMAN Mukesh Kumar Tiwari
EXAM UNIVERSITY INSTITUTION YEAR RESULT (%)
Post graduate Degree
in Biotechnology
Barkatullah
Vishwavidyalaya,
Bhopal
Bhopal [Madhya Pradesh]
2005 56
Bachelor Degree in
Microbiology
Barkatullah
Vishwavidyalaya,
Bhopal
Bhopal [Madhya Pradesh]
2002 65
4