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CURRICULUM VITAE

MANOJ MAURYA
S/o Late Shri Shiv Chand Maurya
H.No-2660/ 3, Gali No. 25 , Sec-23 ,Sanjay Colony,
Faridabad (Haryana).
Mob:- 9205014707, 9818406876
Email:-maurya.manoj2008@gmail.com

Objective:

 Seeking responsibilities and challenging career, where my knowledge, skill effort will be
best utilized for achieving organizational goals.

Educational Qualifications

Degree/Qualify Year University/Board Specialization Percentage

SCIENCE
V.B.S.UNIVERSIT 51.9%
B.Sc.(Z.B.C.)
Y JAUNPUR. (Chemistry)
(2003-2005)

XII U.P. BOARD SCIENCE 61.4%

(2002)

X U.P. BOARD SCIENCE 57.7%

(2000)

Current Job:

Presently working in Medivac Surgical Pvt. Ltd., Bhachau as Quality Manager.

Company Profile:

Medivac Surgical Pvt. Ltd. is an ISO 13485, CE certified Company, manufacturing unit of
Medical Devices & Surgical Disposables: producing Intravenous Set, Blood Transfusion Set,
Measure Volume Transfusion set, 3-Way Stop Cock, Extension Set, Pressure Monitoring Line,
Hypodermic Syringes, Hypodermic Needles & Cannula.
Responsibilities:
 Overall in-charge of documented information’s, External audits in compliance with MDD-
93/42/EEC, ISO 13485, ISO 9001(QMS) and customer audits.
 Managing and maintaining compliance with Certification of ISO 13485 requirements
(including leading Surveillance and Recertification Audits), CE marking of products in
compliance with MDD 93/42/EEC (including assembling and revising Technical Files and
Device Master Records)
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 Responsible for the Deviation & CAPA system including owning and driving the
investigation, root cause analysis, corrective action implementation, and verification of
effectiveness for timely closures of CAPAs.
 Responsible for monitoring the customer complaint system (including returned good and
complaint investigations), trending complaint data, and reporting at Management Review.
 Responsible for working with R&D and manufacturing to develop validation protocols for
production processes. Performing the risk assessment as per ISO 14971.
 Responsible for all external and internal audits (including conducting internal audits,
managing external audit schedules, directly facing auditors during Regulatory Agency
audits, and corresponding with Regulatory Agencies on audit findings and closure)
 Monitoring and Ensuring compliance of product labeling and marketing materials.
 Responsible for Supplier Evaluation & Qualification, supplier audits, and ensuring the
Approved Supplier List updated and maintained.
 Monitoring the Material management process (Procurement, Warehouse) and ensuring the
material stocks are maintained, updated in ERP MEDICORE.
 Responsible for Document Control and processing all document change requests.
 Responsible for leading and conducting Management Review including trending, metrics,
and objectives with collaboration and input from other departments
 Responsible for establishing the company quality objectives and quality plan on an annual
basis
 Monitoring & ensuring the issuance of BMR, Test plans and reconciliation.
 Monitoring & ensuring the Products are dispatched after inspection.
 Monitoring the internal & external issues, compliance issues and process changes and
communicated to management through MRM for continual improvement.
 Performing the gap analysis as per time interval and for fulfillment of the requirements as
per standard requirements.
 Executed the internal audits in the facility, follow-up audit and fulfilment of corrective
action.
 Conducting vendor audit and documentation for supplier’s qualification.
 Reviewing and approving of all QC, Production, and supporting department documented
information’s.
 Monitoring of Manufacturing Formula records, Product development records, Batch
initiation records, Stability Protocols, Validation Master Plan, and Process Validations.
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 Preparation, review and control of raw material, Packing materials, finished products and
intermediate specifications and testing methods.
 Review of analytical reports of raw materials, finished products and maintained the
availability of stock for business continuity.
 Responsible to monitor & document the incidents, ensure the Root cause analysis,
correction, corrective action, post implementation, impact analysis, risk assessment and its
documentation.
Achievement:
 I have recently cleared the IMDR Audit & closed the Discrepancy for Manufacturing
License through TUV SUD notified Body.
 I have recently cleared the ISO 13485 & CE Audit & closed the Discrepancy for getting CE
mark through TUV SUD notified Body.
 Make a standard and implement in organization to smooth operate the process.

Professional Experience:

 2.5 years experienced in Gujrat Environmental & Infrastructure Pvt. Ltd. as Sr. Lab Chemist
in laboratory from March 2015.

Company Profile

Gujrat Environmental & Infrastructure Pvt. Ltd. is a global, broad-based Enviro-infrastructure

company devoted to discovering new methods, new technologies and new ways to aid waste
recovery, recycling and help build a sustainable environment.

Responsibilities:
 Preparation of solution & standardization.
 Heavy metal analysis on AAS & Spectrophotometer.
 COD testing.
 Sample collection, Data preparation & report preparation, fingerprint analysis &
Consignment sample.
 Preparing recipe of AFRF
 Worked on SAP Software & connect of google chrome.
 Ambient Air Monitory (RSPM, SPM, SOS, NOS)
 Calibration record & maintenance of instruments.
 Maintain the routine & periodic testing records.
 Performing the gap analysis as per time interval and for fulfillment of the requirements as
per standard requirements.
 Executed the internal audits in the facility, follow-up audit and fulfilment of corrective
action.
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 Monitoring and Ensuring compliance of customer & markets complains.

Professional Experience:

3.5 years experience with Hindustan Syringes & Medical Devices Ltd. Ballabhgarh Faridabad as a
Pharmacist cum Sr. Supervisor in Quality Assurance in plant 3rd lab (central lab).
 Proficient in leading teams for running successful process operations & experience of
developing procedures.
 Well versed with the concepts of 5‘s’ and ISO Documentation.

Company Profile:

Hindustan Syringes & Medical Devices Ltd. (I.S.O –9001, 13485, 93/42/EEC ) Ballabhgarh
Faridabad (Haryana) manufacturer of syringes & medical devices. Medical devices- I.V. cannula,
Surgical blade, Scalp vein infusion set, Blood collection tube, Blood collection needle, Needle.
Syringes –Insulin syringes, Syringes, Kojak selinge (A.D)

Chief
Chief Tasks Handled
Task Handled

 Ability to analyze problem.

 The ability to take the initiative and work autonomously to solving problems in their area of
responsibility.
 Manual, Machine & Chemical testing of product (Tests as per I.S.O. standard & company
standard for the product).
 Testing of Finished product & making certificate of analysis.
 Evaluation of mold component, molding pin.
 Study of real time stability, product performance.
 To take corrective/preventive action on product.

Responsibilities

In Quality Assurance lab.

 Chemical testing like ph measurement, acidity/alkanity of cannula, catheter,

Biocompatibility of syringes, suitability of incoming material.
 Use of vernier, micromemetre, profile projector & vms.
 Sharpness test, plunger movement on me lab penetration m/c .
 Bar code stickers.
 Trained the new comes workers.
 Evaluations of sterilization parameter, Batch production record.
 P.D.I inspection.
 Chemical preparation for blood collection tube.
 Finished test report of product & certificate of analysis.
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 To take corrective/preventive action on product.

In Molding area:-

 Evaluation of molding pin, component, molded sample as per drawing,

 Evaluation of component, molded sample against the defects.
 Evaluation of molded sample as per dimensional, operational.

In Assembly area:-

 Suitability of samples.
 Evaluation of products as per dimensional (as per drawing), operational.
 Evaluation of products defects.
 Tests of product as per I.S.O. standard & company standard for the product.

In Packing area:-

 Evaluation of packed product (e.g. sealing,)

 Evaluation of packed product marking as per requirement.

Computer Proficiency:

 Operating Systems : MS Office, using E-Mail & Internet

 Operating Systems : Micro view system.
 Others : Certificate in first Aid,
Area of interest : Evaluation of product, study for different types.

Projects:

Project Title :. Development of “Clip Vein I.V.CANNULA”

Project Description:

 Clip vein Which is safe for user.

Personal Information:

Father’s Name : Late Shri Shiv Chand Maurya

Date of Birth : 20 July, 1986
Marital Status : Married
Hobbies : Reading books, Watching Movies.
Temporary Address : 22 feet Road, Sanjay Colony, Gali No-E25,
H.No- 2660/3, Near Jai Durge School, Faridabad
E-mail ID : maurya.manoj2008@gmail.com

Declaration:
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I, Manoj Maurya hereby declare that all the information mentioned above is true to the best of my
knowledge.

Place:

Date: Manoj Maurya