Quality Control

MANOJ DATTATRAY RAUT

Mobile: 097******** ~ E-Mail: ****.***@**********.***/ ********@*****.***

[pic] Seeked assignments in Production cum Regulatory Affair with an

organisation of high repute in Pharma industry.

Snapshot

A professional with 2 years of experience in Production Management, Quality

Assurance and Operations Management in the Pharma industry. Proficient in

developing & streamlining systems with proven ability to enhance

operational effectiveness and meet operational goals within the cost, time

& quality parameters. Well versed with scaling up productions techniques,

Quality Control Techniques/Instrumentation and Regulatory Section.

Experience in conceptualising profitable production projects and managing

operations encompassing procurement, quality and industrial relations. Deft

at managing the validation & calibration of systems and review of

departmental documentation. Possess strong research, analytical, problem-

solving and interpersonal communication skills.

Professional Experience

Production Executive -with Edge Pharma Pvt. Ltd.

Since Mar'11- Apr '13

CHIEF TASKS:

Pharma Production

< Overseeing production of various Formulations and implementing plans with

a view to ensure timely accomplishment of production targets within the

quality and cost parameters.

< Looked after the stock availability of products, Raw Material, Packing

material and Inventory control.

< To review Production Documents (BMR & BPR).

< To check & control IPQC parameters of Formulation/product.

< Ensuring quality product delivery; managing overall operations involved

in production planning including coordinating in marketing, R&D dept, QC

Dept, regulatory Dept, supplies and up-time of equipments.

< To dispatch the Consignment to different countries (Russia & CIS

countries).

< To provide the documents required for Products export.

Quality System Implementation / Process Improvement

< Setting up facilities in the organisation to spearhead quality management

initiatives.

< Establishing quality management systems across various processes to meet

the pre-set quality standards and reduce rejection levels.

< Pertaining to quality implementation and productivity improvement.

NOTABLES:

< Handled the Loan License site.

< Ability to interpret the Analytical reports.

< To perform Costing of products as per DPCO

< Responsibilities regarding Regulatory Activities which are as follows:

< How to apply for the WHO-GMP Renewal, loan License, COPP and

Neutral code.

< National Dossier/ACTD Dossiers checking and preparation for

different countries' like Russia, Kazkistan, Tajikistan and

Belorussia.

< To reply the queries from MOH of various countries.

< To send the samples for registration to different countries.

< To coordinate with different departments for completing the

regulatory requirements.

< Familiar with COPP and FSC regulatory Documents.

< Have a sound knowledge of bioequivalence Study, Summary Product

Characteristics, Drug master file.

< 5% escalation in productivity through efforts.

< Appraisal received within 3 months with job confirmation.

Academia & Credentials

2011 M.Pharm. (Pharmaceutical Chemistry) from Pune University, Siddhant

College of Pharmacy, Pune. Secured 68.0%.

2009 B. Pharmacy from Shivaji University, Rajarambapu College of Pharmacy,

Sangli. Secured 65.64%.

2005 XII from Maharashtra State Board, Walchand College of Arts &

Science, Solapur. Secured 66.36%.

2003 X from Maharashtra State Board, Guru Nanak English High School,

Andheri (E), Mumbai. Secured 78.86%.

Other Qualification

2011: Certificate course in Diploma in Intellectual Property Law from

Bharati Vidyapeeth University.

Summary of Intellectual Property Law related knowledge:

< Patent law

< Copyright law

< Trademark Law.

< Industrial Design and Geographical Indication.

Trainings Attended

Serum Institute of India, Pune

One Month

< Attended industrial training in, Serum Institute of India, Pune as a part

of the curriculum.

< Got the opportunity to learn and work in the departments of Test

Laboratory, Q.C & Q.A., Regulatory Department & Production Department.

Hindustan Antibiotics Ltd., Summer Trainee

Sep '10- Mar'10

< Actively took training in Quality Control, Quality Assurance and

successfully carried out project in Analytical Chemistry Department &

handled various instrument and also prepared various documents.

< Key instruments/ document prepared are as follows:

< UV-Spectrophotometer, Shimadzu, Model No-1601.

< High Performance Liquid Chromatography, Agilent 1200 Series and

Dionex.

< Dissolution Apparatus, Electrolab.

< IR-Spectrophotometer, Shimadzu.

< Validation Document.

< Annual Product Review (APR).

Academic Project

Review study : "Life style Drugs" (B. Pharmacy)

Study Duration : Sep'08-Mar'10

Guide: Prof : Mr. Ganesh Wadakar (M. Pharm), R.C.P, Sangli.

Research Article

< " An Analytical RP-HPLC Method Development and Validation".

< "An Analytical UV-Spectrophotometric Method development and Validation".

(for M. Pharm academic year 2010-2011) Guided by: Dr. H. K. JAIN

(S.C.O.P,Pune)

< An Analytical HPLC Method development and Validation". (for M. Pharm

academic year 2010-2011) Guided by: Dr. H. K. JAIN (S.C.O.P,Pune)

Academic Attainments

< National level Pharmacy Talent Exam, Rank 48.

< Attained National level Conference of "APTI".

< A Paper Published in, "International Journal of Chemtech Research" in

Vol.3, No.3, pp 1506-1510, July-Sept 2011.

Extramural Engagements

< Arranged for seminars and presentations in the college.

< Actively participated in:

< Dance competitions both at School & College level.

< Sports both at School, College level & University level.

< Poster & Paper Presentation at inter-college level.

IT Forte: Well versed with Windows 98 & 2007, MS Office, and MS-Excel &

Internet Applications.

Personal Dossier

Date of Birth: 21st August, 1987.

Address: S. No 165, 1 A, PL 45, Indira Nagar, Chinchwad, Pune -411

033

Languages Known: Marathi, English and Hindi.

Preferred Location: Maharashtra

References :

1. Mr.Navin Khare,(M.Pharm)

D.G.M OF QCL,

Hindustan Antibiotics Ltd, Pune- 18

Contact No.937******* .

2. Mr. Anil W. Pradhan,(President -Operation)

EDGE PHARMA Pvt.Ltd.

Contact No.982-***-****

Contact this candidate