Regulatory Affairs Training Hyderabad : www.digvijaya.com MANAGEMENT CONSULTANTS

[Admin]

DIGVIJAYA MANAGEMENT CONSULTANTS PVT.LTD.,
http://www.digvijaya.com

Keywords: R.A Training

Designation: Regulatory Affairs Training
Experience: 0 - 2 Years
Location: Hyderabad / Secunderabad
Education: UG - B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy,M.Sc - Any Specialization
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Engineering Design, R&D
Posted Date: 25 Nov 2008

Job Description
Job oriented training on Regulatory Affairs.
Duration of the course: 30 days
Eligibility: M.Sc/B.Pharmacy/M.Pharmacy with 0-2 yrs exp.

Desired Candidate Profile
Trainers are from reputed pharma industries. Fresh batch is commencing from 1.12.08.

Company Profile
Job Oriented training for Regulatory Affairs

Executive Name: Smruti Ranjan

Address:
4D, 4th Floor, Nandanavanam,
SR Nagar 'X' Roads,
Hyderabad,Andhra Pradesh,INDIA 500038

Email Address: trainingra@gmail.com

Telephone: 91-040-23817576

[manjusha]

i have completed my bpharm recently. i m intersted in regulatory affarirs.can u please tell me when the training starts and commencement of classes.

[Guest]

visit www.clinnov8.com for more details or call 9052643068

[Guest]

Resume
Shantiprasad B. Babhale
Email : yashtej007 AT yahoo.co.in
Shantiprasad007 AT gmail.com

CAREER OBJECTIVE
To gain professional expertise through industrial experience, with an overall personality development in order to face the challenges ahead and understanding the need for performance oriented drives and striving for the best.
EDUCATION

Examination College/University Year Percentage
PG Diploma in RA BII Noida 2010 Appearing
B.Pharm Sitabai Thite College of pharmacy Pune University 2009 67.66%
D.Pharm D.S.T.S. Mandals College of Pharmacy Solapur
MSBTE Board, Mumbai. 2006 78.6%
HSC Maharashtra Board 2004 73.00%
S.S.C Maharashtra Board 2002 77.46%
WORK EXPERIENCE
- Working in Cipla Pharmaceuticals Ltd. ,Goa as QA Officer from December 2009 . ( 1 year experience )
JOB SKILLS
- Assurance of quality at each stage of Manufacturing to packing.
- Inprocess checks
- Line clearance at all stages of manufacturing and packing.
- Proof checking
- Process Validation compilation and sampling
- Review of Batch records.
- Draft checking of BMR and BPR.
- Batch Release .
RESEARCH PUBLICATION
1. Publication of research paper in “ JOURNAL OF PHARMACY RESEARCH” Vol.2 , May 2009 titled “ Antilithiatic activity of Achyranthus aspera linn. Leaves extract on Ethylene Glycol induced Nephrolithiasis in Wister rats “ in B.Pharm.
2. “Aviskar -2008” Paper presentation at Baramati in B.Pharm.
OTHER ACHIEVEMENTS
3. Pharma Quiz Competition Ist Prize in Diploma.
4. Drug Information Seminar Ist Prize in Diploma.
5. Participation in Medical Detailing Competition” in Diploma.
TECHNICAL QUALIFICATIONS
- Certificate course in MS-CIT
STRENGTHS
- Have sportive and positive attitude
- Hard-working
- Always in a learning mode

[Guest]

RAMAKRISHNAN MAHADEVAN
r.mahadevan87 AT gmail.com
Regulatory Affairs & Quality Management Systems
Seeking executive level assignments in Regulatory affairs – To acquire FDA & CE approval for medical devices/ QMS (ISO 13485 :2003, ISO 9001:2008).
PROFILE & STRENGTHS
Competent, diligent & result oriented professional, offering around 2 years of experience in Regulatory affairs with roles & responsibilities involving documentation and submission of design documents for 510(k)-US FDA & CE- EU approval.
Competent in Quality Management System (QMS) as per ISO 9001 :2008 & ISO 13485 : 2003.
Knowledge of preparing and maintaining Design related documents & QMS related documents.
Competent in ISO 13485 : 2003 (Quality Management System for Medical Device).
Knowledge on device clasification for US & EU markets.
Knowledge on the regulatory requirements for medical devices such as advisory notice issuance, vigilance system, Notifications and incident reporting to Notified Bodies (NB), Notification of significant change to NB/Regulatory Bodies.
Knowledge of cGMP / GLP.
Dexterity in defining SOP's to enhance operational effectiveness of the company thereby improving Customer satisfaction.
(Caretaker) Management Representative – ISO 9001 : 2008 & ISO 13485:2003
Conversant with QMS Auditing.
Demonstrated ability to manage human, financial and material resources towards the achievement of stated objectives, to plan and manage work programmes and to lead, motivate and provide effective guidance to a team of professional and support staff.
Demonstarted ability to perform process and product Risk management, FMEA.
PROFESSIONAL EXPERIENCE
DYANSYS INDIA PVT LTD Since Sept’10
Executive – Regulatory affairs
Key Accountabilities :
Familiar with Review and compilation of documents like SOPs, Product realization protocols, Input-Output design protocols, Process-Product verification & validation protocols and reports.
Ensuring compliance with IEC standards including testing of devices at testing centres.
Classification of devices & documenting device master records for submission to US & EU.
Handling and monitoring/coordination of all in-process Quality Assurance activities.
Monitoring quality management system and ensuring it is compliant to current ISO 9001 :2008 & 13485:2003 requirement.
Extensive experience in ISO 13485 :2003 and operational knowledge of manufacturing, quality assurance, project management and operations management Impart training related to new updates in process and Quality systems.
Co-ordinating ISO Team Leaders and Internal Auditors and formulating reports on the status of quality management system.
Controlling the QMS to build best-practices and standards.
Coordinating about performance of quality management system to top management.
Preparing specification control drawings for electronic & mechanical components for design, datasheet extraction.
Creation of Bill of Material (BOM) and incorporating Engineering Change Note (ECNs) to capture changes in BOM.
Notable Accolades
Responsible for the timely completion & submission of 510(k) documents for Portable ANSiscopeTM.
Won praise from the top management for gaining rapid knowledge in creating specification control drawings.
Responsible for creating appropriate design documents for all products & ensuring sufficient evidence maintenance from the base-level.
Recently promoted as Officer - Regulatory Affairs.
EDUCATIONAL & PROFESSIONAL CREDENTIALS
Masters degree in Biomedical Engineering, 2010
University of New South Wales, Sydney, NSW, Australia
Bachelor of Technology in Biomedical Instrumentation Engineering, 2008
SRM University, Chennai, TN, India
Computer Proficiency
Windows, Linux. Fundamentals, MS-Office, Coral Draw, Matlab, labVIEW.
Professional Training
“Quality Management Systems” Conducted by Sankalp consultants at DyAnsys India Pvt. Ltd.
“ISO 13485” Conducted by Sankalp consultants at DyAnsys India Pvt. Ltd.
“Risk Management” Conducted by Sankalp consultants at DyAnsys India Pvt. Ltd.
IT Skills
MS office tools like MS PowerPoint, MS Word & MS Excel