Electrolab Pvt Ltd Mumbai : Documentation Engineer

[mskavi]

Electrolab India Pvt Ltd Mumbai, Navi Mumbai : Documentation Engineer

Designation: Documentation Engineer
Experience: 1 - 2 Years
Location: Mumbai, Navi Mumbai

Job Description:
Should have a good knowledge of technical jargons and documentation work of Design. With excellant communication skills and very fuent english.

Desired Candidate Profile:
Familiar with Technical documentation work. Designs and other related work responsibility.

Company Profile:
Mfr. of Pharmaceutical lab testing equipment

To apply, send CV to Email Address: hr@electrolabindia.com
Website: http://www.electrolabindia.com

Keywords: Documentation Engineer

[Guest-IJT]

Mr. K.LAKSHMAN (M.Pharm)
lakshmankamble AT yahoo.com
lakshman.kamble AT gmail.com

Applied For
:
Regulatory Affairs ( Executive)

Job Objective I want to become a part of the dynamic environment and utilize the resources to make constructive difference in an esteemed organization and to accelerate my career.
M.pharm Dissertation FORMULATION AND EVALUATION OF HERBAL COSMECEUTICALS.
TOTAL PROFESSIONAL EXPERIENCE : 1 Year 6 Months (Industrial & Academia)
Organization LEARNERS LAND COLLEGE OF PHARMACY, Warangal.
(The college has approved by AICTE and Pharmacy Council of India,
New Delhi and is affiliated to JNTU, Hyderabad.)
Department
DEPARTMENT OF INDUSTRIAL PHARMACY

Designation Asst. Professor
Responsibilities Taught theory and practicals in Biopharmaceutics and Pharmacokinetics, Advanced Industrial Pharmacy, Pharmaceutical Technology, Physical Pharmaceutics, Pharmaceutics and Pharmaceutical Engineering, for undergraduate students.
During the teaching carrier successfully handled a number of academic related responsibilities such as Paper setting, Valuation, Co-ordinator for valuation, Observer for university and board level examinations.

Organization MEDREICH LIMITED, Bangalore a TGA, MHRA, MCC approved Company (March 2010 – Till Date)
Department Regulatory Affairs (Officer Grade1)
Responsibilities Ability to work independently as well as a part of a team, to manage, steer and execute tasks to completion.



- Participation in the regulatory review of Artworks (Carton, Foil, PIL) according to country guidelines and coordination with packaging, R&D, IBD and customer country.
- Preparation of Clinical and Non Clinical Overviews (Module 2.4, 2.5, 4.2, 5.4) for CTD filing.

- Participation in the preparation of SmPC, Clinical Literature referenses
- Participation in the regulatory review of BA/BE study report and coordination with CRO’s.
- Knowledge about Sch Y, GCP, D&C Act 1945 Rules.(Schedules, Forms)
- Participation in the preparation and review of domestic regulatory documants such as Product Licence, COPP, FSC, Test license, Manufacturing Licence, DCGI for NOC, Neutral Codes etc.,

- Participation in the regulatory review of PIF’s and Change Controls and coordination with IBD, R&D, Packaging, CQA, CQC, PPIC,CTT.,

- Coordinate with outsourcing Manufacturing Units for Collection of documents for compilation of dossier.

- Familiar with various regulatory guidelines (ICH, MHRA, TGA, MCC, NAFDAC, HSA, CDSCO,USFDA, WHO, EDQM) and Current edition of Pharmacopoeias’ ( IP, BP/Ph.Eur, USP,)

- Handling queries related to Artworks, Clinical Overviews, BA/BE and licensing documents.

Recognition Received :
- Qualified GATE 2007 with All India 980 rank
- Qualified GATE 2006 with All India 2800 rank
- Receiving AICTE Scholarship at M. Pharm. Level.
- Secured 56 rank in N.I.P.E.R Entrance test 2006
- Participated in various events of sports and cultural activities at School and college level
Workshop & Papers Presented :
- Participated in Quality Improvement Programme (QIP) on "Innovation in pharmaceutical technologies and Drug Delivery System" at Kakathiya University College of Pharmaceutical Sciences Warangal, sponsored by AICTE, New Delhi.
- Participated in 57th IPC held at Hyderabad
- Participated in National Conference held at Kakatiya University ( 28th ,29th Oct 2005)
- Participated in Blood Donation Camp Conducted by Red Cross society in the year 2005 at
Talla Padmavathi College of Pharmacy, Warangal.
Publications :
- A paper entitled “NANOPARTICULATE DELIVERY OF LORATADINE USING POLY (e-CAPROLACTONE) FOR SUSTAINED RELEASE” is under communication to be published in International Journal of Pharmaceutics.
- Presented a Paper on SIMULTANEOUS SPECTROPHOTOMETRIC ESTIMATION ON DOMPERIDONE AND METRONIDAZOLE in Tablets in PHARMA FLAIR at Balaji Institute of Pharmaceutical Sciences, Narsampet , Warangal on Oct. 7,8 . 2008
Computer
Proficiency - Well versed with Ms-office and Internet surfing.

- SAP, Tally Software’s.
Regulatory guidelines proficiency : - Aware about ICH, WHO, TGA, MCC, NAFDAC, HSA, CDSCO, USFDA, EDQM
- Aware about CTD, ASEAN Common Technical Document & Medicines Control Council guidelines
- As a part of review team in reviewing of dossiers
- Current Edition of Pharmacopeias (IP, BP, Ph.Eur & USP)
Qualification University College Year Percentage
M. Pharm
(Industrial Pharmacy)
Kakathiya University
Warangal University College of Pharmaceutical Sciences. (AP)
2009
71.00%
B. Pharm
Kakathiya University
Warangal Talla Padmavathi College of Pharmacy 2006
67.00%

Personal Details
Date of Birth 15.07.1981
Marital Status Unmarried
Languages Well versed with English, Hindi, Telugu, Marathi, and Kannada
Hobbies Learning new things.

Declaration
I here by declare that the above information provided is true to the best of my knowledge.