Curriculum Vitae

MANOJ KUMAR
H.NO. - 1388, Sec.-4,
Rewari (HARYANA)
Phone no.:+919729072658
Email Address: - manojyadav0209@gmail.com
OBJECTIVE:

To work in a creative and challenging environment, in order to utilize my skills and abilities
with support of my team to achieve the goals of organization, where I could constantly learn
and successfully deliver better results and innovative solutions to all problems and could
become a better human being in the process.

PROFESSIONAL EXPERIENCE

Currently working with “Hollister Medical India Pvt. Ltd, Rewari (HR)” from September 2013
as “Quality Inspector in Quality Assurance Department”.

Key Highlights:
Internal Auditor (ISO 13485:2012)

Knowledge of ISO 21 CFR 820, ISO 13485, ISO 14644, Schedule-M, ISO 14971 (pFMEA), 7QC
Tools

ORGANIZATION:
Hollister Medical India Private Limited is a manufacturing facility of continence care
products in compliance with the requirements of USFDA, NSAI and ISO 13485 stand and wholly
owned subsidiary of Hollister Inc., USA.

Hollister’s Immutable principles- Stewardship, Service, Integrity and Dignity of the person

JOB RESPOSIBILITIES:

 Documentation of quality processes as per ISO 13485, Schedule-M and USFDA

requirements,

 Internal Audit as per in compliance with ISO 13485.

 Process monitoring using statistical control charts

 Review of BMR/DHR (Device History Record)

 Release of finished goods in SAP system

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 Curriculum Vitae
 Roving audit of Shop floor as per written procedure to prove compliance with GMP

 Handling of nonconforming material and NC

 Preparation & control of documents in “Qumas” – regulatory complying software for

Electronic document and process management

 Participate in 6-S and CAPA activities

 Participate in pFMEA activity as per ISO 14971 (Risk management for Medical Device)

 Preparation and review of validation protocols

 Participate in validation activities

PREVIOUS EMPLOYER:

Previously worked with Alliance Formulations (TP of J&J), Baddi (HP) for a period of 2
years from 17th July 2011 to 30th August 2013 as Executive-Microbiology & QA.

JOB RESPOSIBILITES:

 Issuance and review of Executed BPR/BMR for routine batches

 In Process Quality checks & sampling of In-process samples & finished product samples in the
Manufacturing, and Packaging as per procedure

 Preparation, Review, control and Maintenance of controlled documents and records

 Online QA audit to ensure that all work in manufacturing and supporting departments is in full
compliance with GMP & SOP.

 Preparation of calibration/validation matrix, preparation of reports for calibration and

validation.

 Handling and maintain data of Change control, Deviation Control

 Participate in Investigation and preparation of data for customer complaint, Internal Failure,
NC, CAPA

 Planning and execution of utility qualification /requalification in the facility in line with
regulatory & GMP requirements.

 Preparation of IQ/OQ/PQ/RQ protocol & report of utility in the facility (like. HVAC , purified
water system)

 Environmental monitoring of clean rooms by settle plate, Active air sampling, surface
monitoring and personal monitoring

 Sampling of In-Process as well as Finished Products and Water Systems at various specified
points.

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 Curriculum Vitae
 Conduct Microbial Testing of Raw Materials, Finished Products and Water Systems.

 Maintaining microbial cultures in passages periodically as per the stipulated scheme.

 Development & implement of Test Method Validation protocol

Equipment, Utility Qualification / Requalification Activities:

 Validation/Qualification-Water system, HVAC, Autoclave, Clean Room, Incubator, Test Method,

Process validation, cleaning validation.

INDUSTRIAL TRAINING:

I did internship with “ABBOTT HEALTHCARE PRIVATE LTD., BADDI (H.P.)” as trainee since 1st Feb
2011 to 30th April 2011 for three months in Quality Control (micro-bio) department on a project
“Manufacturing, In- process and Microbial Testing on Plasma Expander (HAEMACCEL)” as the
partial fulfillment of degree

EDUCATIONAL QUALIFICATION

 Along with profession completed MSc. in Microbiology from NIMS University, Jaipur in 2012-
2014 with 64% marks.
 B.Tech. (Biotechnology) from Rajasthan Technical University, Kota in 2011 with 68%
marks.

COMPUTER SKILLS:

 MS-Office (Excel, Word, PP).

 Internet. Browsing

COMPETENCIES:

 Collaborate with team to achieve goals of organization.

 Hard working and detail-oriented. Efficient, and motivated
 Zeal for learning new things
 Dedication to complete a particular work within a given time

HOBBIES AND INTERESTS:

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 Curriculum Vitae
 Swimming
 Play volleyball
 Listening soft music
 Surfing social sites.
PERSONAL DETAILS:

Date of Birth : 02nd Sep 1990

Father’s Name : Mr. Rajmal
Marital Status : Unmarried
Sex : Male
Language’s Knowledge : Hindi, English,

Permanent Address : Mehtawas, Tehsil- Behror

Distt.- Alwar (Rajasthan)

I hereby declare that above-mentioned information is correct up to my knowledge and I bear

the responsibility for the correctness of the above mentioned particulars.

Place: Rewari (Haryana) Manoj Kumar

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