GLP Auditor Jobs Lucknow : ClinTech Research India Pvt Ltd

[muthukalee]

GLP Auditor/Monitor

Responsibilities :
* Assure contract laboratories conducting or supporting nonclinical development are qualified from the GLP compliance perspective prior to use.
* Inspects each non-clinical laboratory study at intervals adequate to assure the integrity of the study and that any problems determined through inspections which could affect study integrity are brought to the immediate attention of the study director and management.
* Periodically submits to management and the study director written status reports on each study, noting any problems and corrective actions taken.
* Determines that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation
* Reviews the final study report to assure the report accurately describes the methods and standard operating procedures, and that the reported results reflect the raw data of the nonclinical laboratory study.
* Partner, interact closely and establish strong liaison with global business partners in Research & Development
* Identify opportunities for process improvement; plan, implement and evaluate changes in conjunction with corporate and department goals.
* Assist in the review and development of Nonclinical Development SOPs and Working Practices.
* Assist in preparation of budget and strategic plan for GLP studies.
* Perform other duties as assigned by the management.

Qualification/Requirements :
* 2-5 Years of experience in conducting nonclinical laboratory studies and auditing nonclinical studies for compliance with Good Laboratory Practice (GLP) regulations in the pharmaceutical industry or contract laboratories.
* Thorough knowledge of the nonclinical drug development process
* Thorough understanding of FDA GLP regulations, OECD GLP Principles and local GLP requirements
* Excellent interpersonal, facilitation, presentation and communication skills with demonstrable tact and diplomacy
* Experience developing, implementing and evaluating SOPs
* Proficient in use of MS Office (Word, Excel and Access)
* Willingness to travel - regional, national and international including overnight stays

If you have relevant experience and would like to be part of ClinTech Research family, please send your resume to career@clintechresearch.com for further consideration.

Contact us :
CLINTECH RESEARCH India Pvt. Ltd.
Biotechnology Park,
Sector - G, Jankipuram
Lucknow, UP 226021, INDIA
Tel. : +91 (522) 4045207
http://www.clintechresearch.com

[Guest-IJT]

Name : Mohd Zafar
Email : cszafar AT gmail.com
Designation / Skillset : Company Secretary

Resume :

Career Objective :
Seeking a challenging and rewarding opportunity in the industry which is in line with my academic & professional background and which effectively utilizes my analytical and technical skills.
PROFESSIONAL EXPERIENCE
1. RANJEET PANDEY & ASSOCIATES Company Secretaries, New Delhi a firm of Company Secretaries engaged in rendering of Secretarial and Legal consultancy services.
Associated from 16th June, 2011 to till date.
2. PRAGYESH SINGH & ASSOCIATES (Company secretaries), Lucknow, a firm of Company Secretaries engaged in rendering of Secretarial and Legal consultancy services.
Worked as CS Management Trainee from 15th Sep, 2009 to 19th Apr, 2011.
Responsibilities and Assignments Handled
Under Company Law
General
Annual Filings and filing of other standard e-forms on MCA.
Maintenance of statutory register.
Search and status reports.
Compliance certificates
Online inspection on MCA and physical inspection with ROC..
Formation of company
Director Identification Number (DIN) and Digital Signature Certificate (DSC).
Name Approvals.
Incorporations of Private Ltd., Public Ltd.,
Change of name.
Alteration of object clause.
Shifting registered office - state to state and within local limits and one state to another state.
Increase in capital.
Charges
Registration of Charge.
Satisfaction of charge.
Section 141 petitions for condonation of delay in registration / modification of Charge.
Compliances relating to directors
Appointment.
Resignation related compliances.
Compliance related to meetings
Drafting of Agenda and Notice of AGM and Extra Ordinary General.
Drafting of Directors Report and Annual Report.
Drafting of Annual Return.
Minutes Maintenance.
Compliance under Listing Agreement
Independently preparing and filing of the quarterly shareholding Pattern to Stock Exchanges as required under clause 35 of the Listing Agreement.
Compliance under clause 49 of the Listing Agreement e.g. Preparation and Submission of Quarterly Corporate Governance Report.
Compliances under the clause 16 of the Listing Agreement regarding book closure.
Compliances under clause 47(C) of the Listing Agreement.
Audit
Share Transfer Audit under Clause 47(C) of Listing Agreement.
Capital Reconciliation Audit under Regulation 55A of SEBI (Depository and Participant) Regulation.

Merger and Amalgamation
Drafting of Scheme of Amalgamation.
Drafting of First and Second Motion Application.
Drafting of OL and RD Reply.
Others
Petition to the Company Law Board u/s 17 for Shifting registered office from one state to other state. .
Petition u/s 391 to 394 for merger Amalgamation.
Liaisoning and Correspondence with various authorities i.e. Ministry of Corporate Affair, Registrar of Companies, Regional Director, Officer Liquidator and Stock Exchanges.
Work as a Internal Auditor in a Micro Finance Firm and having the depth Knowledge of its functioning.
Professional Qualification :
Qualified Company Secretary
The Institute of Company Secretaries of India
Educational Qualification :
Bachelor of Commerce in 2009 with 68% from Aligarh Muslim University, Aligarh.
Intermediate in 2006 with 81% from CBSE Board, New Way College, Lucknow.
High School in 2004 with 67% from CBSE Board, New Way College, Lucknow.
Computer efficiency :
Desktop Application : MS-Office
Operating System : Windows (XP,VISTA)

(MOHD ZAFAR)
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More Information about this submission and submitter :-
___________________________________________________
Submission ID : 4354864
Date & Time : 10th Jul 2011 6:12 PM (UTC)
IP Address : 115.240.139.152
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Predicted Country []: India