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 regionDesignation: Sr. Executive - Quality AssuranceAccreditations: 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

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. 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

PERSONAL PROFILE:

EDUCATIONAL PROFILE:

EXAM UNIVERSITY INSTITUTION YEARRESULT

(%)

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

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

4