RESUME

RAKESH PATKAR

Mob. 078********, 073********

Email: aceeu3@r.postjobfree.com

aceeu3@r.postjobfree.com

EXPERIENCE (4.3 year)

* Present time working in Cipla Ltd Indore from 23.04.2012 to till date.

* 1year at 'MODERN LABORATORY, 45-D/2 Sanwer Road, INDORE (M.P.).

* Eleven months experienced in IOSIS REMEDIES, Rajpura road Village-

kheda Nihala, Nalagarh Himachal Pradesh.(Company certified By GMPs &

ISO)

* Industrial training in LUPIN LTD, Mandideep, District Raisen, Bhopal

(M.P.).

APPLY FOR JOB

Quality Assurance (QA)/ Regulatory Affairs (RA)

PROFESSIONAL SUMMARY

Quality Assurance

* Check manufacturing and packing activity as per SOP and maintained the

cGMP and online documentation at the production line.

* Planning and execution of all IPQA activity as per job responsibility

in co-ordination with the production team by production officer, store

officer and engineering.

* Perform the sampling of in process, validation, Quality control

stability sample and media fill sampling.

Documentation

* Review and retrieval MBMR, MBPR, BMR, BPR.

* Issuance and review of log book as per SOP.

* To ensure no delay in daily production report approval and timely

review and submission of batch document for release.

* Review the all complete Analysis report of raw material, finished

goods and water reports.

* Review the reports of ATR, QCPs, stability product.

* Preparation of Technical Information sheet (TI sheet) for water

sampling, media fill.

* Preparation of master protocols for raw materials and Water.

* Preparation of Standard operating procedure (SOP) for all activity

of Quality Control department.

* Preparation of sampling schedule for water.

Regulatory Affairs

* New products projects studies and technology transfer activity.

* Communication with sender and receiving units for procurement and

distribution of documents.

* Responding to HO, RA for timely submission of regulatory and

international market for product registration documents.

* Co-ordination and collecting the documents from various unit

departments to ensure regulatory submission of product documents and

samples.

* Reviewing and approval of master documents as technical services,

reviewing of specification, COAs, Stability and other QC related

documents.

* Arrange PRC/ External review and queries to ensure effective

compliance.

* Ensure timely submission of data of all section (QA/QC/Production) to

PRC for Dossier submission.

* SPMS receiving, issuance and co-coordinating with Packaging

development.

Learning and Development

* Maximize participation in training and implementation the ideas learned

in effective performance.

* Participate in cost saving Project by explore various ideas without

affecting cGMP and quality.

* Supporting team leader by providing timely data/ information.

AUDIT FACED

WHO, USFDA, MHRA etc.

PROFESSIONAL QUALIFICATION

* M. PHARM (2010) from Bhopal Institute of Tech. and Science- Pharmacy,

(R.G.P.V. Bhopal (M.P with 73.59%.

* B. PHARM (2007) from Bhopal Institute of Tech. and Science- Pharmacy,

(R.G.P.V. Bhopal (M.P.)) with 70%.

* I.T.I. Diploma in Computer Operating Programming Assistant (2003),

from Silicobyte Industrial Training Centre, Katni (N.C.V.T. Delhi)

with 70%.

* Diploma in Fine Art (1999) from Sangeet Sadhna Kendra, Katni, Pracheen

Kala Kendra, Chandigarh with 70%

ACADEMICS QUALIFICATION

* Higher Secondary (2002) from Ordinance Factory H. S. School, katni

(M.P. Board) with 58 %.

* High School (2000) from Ordinance Factory H. S. School, katni (M.P.

Board) with 70%.

INDUSTRIAL VISIT

* Glenmark Limited, Goa, INDIA.

* Wyeth Limited, Goa, INDIA.

COMPUTER EFICIENCY

* Proficient in MS Word, MS Power Point, MS-Excel, etc.

CO-CURRICULAR ACTIVITIES

* Actively participated in cultural & sports activities.

* Have participated in INDIAN PHARMACEUTICAL ASSOCIATION in M.P. Pharma

Meet- 2007 at INDORE (M.P.).

* Have participated in 13th National Convention of Society of

Pharmacognosy -2009 hosted

by department of Pharmacy, Barkatullah University, Bhopal

(M.P.).

* Have participated in Health Awareness Camp -2010 at Bhopal Institute

of Technology &

Science-Pharmacy, Bhopal (M.P.)

* Have participated in IPA CONVENTION M.P. Pharma Meet-2011 at INDORE

(M.P.).

PERSONAL DETAIL

Name : Rakesh Patkar

Date of Birth : 20/06/1984

Father's Name : Shri Chhote Lal Patkar

Marital Status : Unmarried

Nationality : Indian

Languages : Hindi, English & Bundelkhandi

DECLARATION

I hereby declare that the above-mentioned information's are

true to best of my knowledge

and belief.

(RAKESH PATKAR)[pic]

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