The Central Drugs Standard Control Organization (HQ), FDA Bhawan, Kotla Road, Near Mata Sundari College, New Delhi -110002 requires Consultants, Technical Data Associates, Data Entry Operators and Office Assistants. These supporting staff will assist Senior Officers in matters related to Administrative & Technical works carried out in the office of CDSCO. Qualification, experience, job description, emoluments etc. for various posts are as under:-
Posts: Consultants, Technical Data Associate
(i) CONSULTANTS Remuneration :-Rs 40,000.00
(a) Professional Consultant (Medical Devices)
Age: 35 - 50 years
Qualification: .
(i) Master degree in Chemistry / Pharmacy/Biochemistry or Degree m Bio-Medical Engineering with 10 years experience in Manufacture/Testing/ Research/Regulatory affairs of Medical Devices.
Job Description:-
1. To collate, compile and analyze the scientific national, international data/regulation of medical devices.
2. To make relevant SOP"s, guidelines and notification for amendments in Schedule M-III and M-IV to Drugs & Cosmetics Rules.
3. Any other duties assigned by Drugs Controller of India from time to time
(b) Professional Consultant (Diagnostic Kit)
Age: 35 - 50 years
Qualification:
(i) Master degree in Pharmacy/ Medical Lab Technology/ Biochemistry/ Microbiology or degree in Bio-Medical Engineering with 10 years experience in Manufactures/ Testing/ Research /Regulatory affairs of Diagnostic kits.
Job Description:-
1. To collate, compile and analyze the scientific national, international data/regulation of Diagnostic kits.
2 To make relevant SOP 's, guidelines and notification for amendments in Schedule M-III and M-IV to Drugs & Cosmetics Rules.
3. Any other duties assigned by Drugs Controller of India from time to time
(c) Professional Consultant (Pharmacovigilance) (Tech.))
Age: 35 - 50 years
Qualification:
Master degree in Pharmacy with pharmacology or clinical pharmacy with 10 years experience in collation/ analysis of ADR reports.
Job description:-
To prepare the blueprint for collection, Collation, analysis of ADR reports, received from various centres all over the country and implementation of the Pharmacovigilance programme. Preparation of guidelines / documentation etc. for the programme. Co-ordination of spurious drugs survey at National Level. Any other duties assigned by Drugs Controller of India from time to time
(d) Professional Consultant (Biopharmaceuticals)
Age: 35 - 50 years
Qualification:
Master Degree in Pharmacy with Pharmacology or clinical Pharmacy or M.Sc. in Clinical Chemistry with 10 years experience in manufacturing/testing/Regulatory Affairs of Biopharmaceuticals.
Job description:-
1. To prepare guideline documents for conducting Clinical Trials, manufacturing and testing of Biopharmaceuticals.
2. To facilitate the preparation of guideline document for approval of New Drugs(Biopharmaceuticals) and for CRO centers.
Any other duties assigned by DCG(I) from time to time.
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(e) Professional Consultant (Clinical Trial)
Age: 35 - 50 years
Qualification:-
Master degree in Pharmacy with pharmacology or clinical pharmacy with 10 years experience in co-ordination/ documentation/ management of Clinical Trial.
Job description:-
1. To facilitate the preparation of SOP's, guidelines, roadmap for registration ol CKOs, Ethics Committees; inspection of Clinical Trial sites, sponsors /CROs ; GCP training etc
2. To facilitate the preparation of guidance document for approval of various categories
of new drugs , clinical trials including micro dosing (phase zero) and phase -I clinical
3. Any other duties assigned by Drugs Controller of India from time to time
(f) Professional Consultant (Cosmetics)
Age: 35 - 50 years
Qualification:-
Master's degree in Pharmacy with 10 years experience in manufacturing / testing of cosmetics.
Job description:-
1. To prepare the SOP's, Guidelines on regulation of import of cosmetics.
2. To maintain Documentation & Data-base
3. any other duties assigned by Drugs Controller of India from time to time
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(g) Professional Consultant (IT Services)
Age: 35 - 50 years Qualification:-
Qualification:-
1. B-Tech /B.E (computer science) or MCA
2. 5 years experience in management/ development of software m a reputed organization.
Job description:-
1. To facilitate E- governance project.
2. To train the staff to implement E- Governance and File Tracking System.
3. Development of electronic Archiving and retrieval system.
4. To maintain Documentation 8s National Data Bank.
5. Upgradation of website and its up keep.
6. Installation of Video conferencing facilities with wi-fi system.
7. Prenaration of user manual etc.
8. Any other duties assigned by Drugs Controller of India from time to time
(h). Professional Consultant (Quality Management System)
Age: 35 - 50 years
Qualification: M.Pharmacy with 10 years experienee in quality management in Pharmaceutical field.
Job description:-
1. to facilitate implementation of quality management system and its monitoring.
2. Training of staff .
3. Harmonization with national/ international QMS progress.
4 To prepare and maintain documentation.
5. Preparation of guidelines/ operating documents for the organization.
6. Any other duties assigned by Drugs Controller of India
ii). Technical Data Associate
Age:- 21-40 Years
Qualification: -
The candidates should be B.Pharmacy or M.Sc. in Biochemistry, Pharmaceutical Chemistry/ Organic Chemistry /Microbiology / Biotechnology. The candidates should also have sound knowledge of computer operation. Preference will be given candidates having experience in manufacturing. Testing of drugs/drugs regulatory affairs.
Job description:-
To assist officers of CDSCO in scrutiny/examination of technical documents pertaining to import registration, Import license, new drug approval, Central License Approving Authority (CLAA) items and various NOCs. Documentation. Creation and maintenance of National Data Bank. Any other duties assigned by Drugs Controller General of India (DCGI) from time to time.
Remuneration :- Rs19000.00-Rs20000.00 per month
Note
1. The Candidates_may send their Resumes to the Representative of M/S Bedi & Bedi Associates at CDSCO (HQ), FDA Bhawan, Kotla Road (Near Mata Sundari College), New Delhi-110002 latest by 10th March, 2013 at 3:00 P.M. The interview call will be given by email/ on mobile, therefore, it is essential that candidate must give their email address/mobile number
2. The candidates should mention on the TOP of envelop “Name of the Post applied for which he/she is willing/applying.
3- A.Soft copy of application may be sent by email to the undersigned at jobs.bedi@gmail.com for information.
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