A. CDSCO (HEAD QUARTER)

(a). Technical Consultant @ Rs.19,250/-p.m.

Qualification:

(i)

M. Pharma with 1 year experience in coordination/ Documentation/ Management of Clinical Trial /Drug information Service/Drug regulatory affairs.

(ii)

One year Diploma/ equivalent course in computers.

Job Description:-

Shall be responsible for maintaining Database of all the activities of CDSCO in HQ, Zonal Offices, Port Offices and Laboratories. He will be assisting office of CDSCO in daytoday activities as assigned from time to time.

(b). Professional Consultant Medical Devices @ Rs.50,130/-p.m.

Qualification:

(i) Master degree in Chemistry / Pharmacy/Biochemistry or Degree in BioMedical Engineering with 10 years experience in Manufacture/Testing/ Research/Regulatory affairs of Medical Devices.

Job Description:

1. To collate, compile and analyse the scientific national, international data/regulation of medical devices.
2. To make relevant SOPs, guidelines and notification for amendments in Schedule MIII and MIV to Drugs & Cosmetics Rules.
3. Any other duties assigned by Drugs Controller General of India (DCGI) from time to time

(c). Professional Consultant Diagnostic Kit @ Rs.50,130/-p.m.

Qualification:

(i) Master degree in Pharmacy/ Medical Lab Technology/ Biochemistry/ Microbiology or degree in BioMedical Engineering with 10 years experience in Manufactures/ Testing/ Research /Regulatory affairs of Diagnostic kits.

Job Description:

1. To collate, compile and analyse the scientific national, international data/regulation of Diagnostic kits.
2. To make relevant SOPs, guidelines and notification for amendments in Schedule MIII and MIV to Drugs & Cosmetics Rules.
3. Any other duties assigned by Drugs Controller General of India (DCGI) from time to time

(d) Professional Consultant Pharmacovigilance (Tech, Admin/ finance) @ Rs.50,130/-

P.M.

(i)Technical

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. Coordination of spurious drugs survey at National Level. Any other

duties assigned by Drugs Controller General of India (DCGI) from time to time

(ii) Administration / Finance

Qualification:

Bachelor degree with 15 years experience in Administration/ Finance in responsible position in Government/ Autonomous organization or PSU.

Job description:

To handle Administrative/ Financial matter in CDSCO. Any other duties assigned by Drugs Controller General of India (DCGI) from time to time

(e.) Professional Consultant Clinical Trial @ Rs.50,130/-p.m.

Qualification:-

Master degree in Pharmacy with pharmacology or clinical pharmacy with 10 years experience in coordination/ documentation/ management of Clinical Trial.

Job description:

1. To facilitate the preparation of SOPs, guidelines, roadmap for registration of CROs, 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 trials.
3. Any other duties assigned by Drugs Controller General of India (DCGI) from time to time

(f).Professional Consultant Cosmetics @ Rs.50,130/-p.m.

Qualification:-

Master degree in Pharmacy with 10 years experience in manufacturing/ testing of cosmetics.

Job description:

1. To prepare the SOPs, Guidelines on regulation of import of cosmetics.
2. To maintain Documentation & Database
3. Any other duties assigned by Drugs Controller General of India (DCGI) from time to time

(g). Professional Consultant IT Services @ Rs.50,130/-p.m

Qualification:

1. BTech /B.E (computer science) or MCA
2. 5 years experience in management/ development of software in a reputed organization.

Job description:

1. To facilitate Egovernance project.
2. To train the staff to implement EGovernance and File Tracking System.
3. Development of electronic Archiving and retrieval system.
4. To maintain Documentation & National Data Bank.
5. Upgradation of website and its up keep.
6. Installation of Video conferencing facilities with wifi system.
7. Preparation of user manual etc.
8. Any other duties assigned by Drugs Controller General of India (DCGI) from time to time

(h). Professional Consultant Quality Management System @ Rs.50,130/-p.m

Qualification: Master degree in Pharmacy with 10 years experience 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 General of India (DCGI) from time to time

(i). Technical Data Associate @ Rs. 17270/-p.m.

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 manufacturer/ testing of drugs/drugs regulatory affairs.

Job description :-

To assist officers of CDSCO in scrutiny/examination of technical documents pertaining to import registration & license , new drug approval, Central Licence Approving Authority (CLAA) items and various NOCs. Documentation, Creation & maintenance of National Data Bank. Any other duties assigned by Drugs Controller General of India (DCGI) from time to time.

(j). Data Entry Operator @ Rs.7700/-p.m.

Qualification: The Candidates should be Graduate with 1 year Diploma in computers from recognized Institute. The candidates should have typing speed of 40 w.p.m. Preference will be given to candidates also having short hand knowledge.

Job description :-

Typing of various letters , approvals, licenses, noting etc. alongwith documentation, Creation & maintenance of National Data Bank. Any other duties assigned by Drugs Controller General of India (DCGI) from time to time.

(k).Legal Consultant (1 Posts) @ Rs.28,600/-p.m.

Qualification:

Essential: Graduate in Law with Chemistry as subject in 10+2 level.

Desirable:

i) Diploma in IPR Laws. ii) Experience in the field of patent and drug law (1 to 2 years) iii) Wellversed in patent laws and TRIPS iv) Experience in drafting patent matters and handling of court matter

Job Description:

i) To Process representations received in the office of CDSCO with respect to Patent data protection, data exclusivity etc. of drugs. ii) Assisting the office of CDSCO in framing replies in the matter relating to patent and other legal matter. iii) Keep an update on the latest development in the field of patent laws national

and international and apprising the same to office of CDSCO iv) Preparation of operational guidelines / interpretation of Drug Rules v) Preparation of manual based or court judgements. vi) Handling of Courts cases and monitoring & followup

vii) Any other duties assigned by Drugs Controller General of India (DCGI) from time to time.

(l).Office Assistant @ Rs.4840/-p.m.

Qualification: The candidates should be 12^th pass.

Job description :-

To help technical staff in daytoday work including movements & maintenances of files, record keeping, dak distribution etc. Any other duties assigned head of the section/division from time to time.

(J). Admin/ Financial Consultant @ Rs. 19,250/-p.m.,

Qualification:

Graduate with 5 years experience in Administration / Finance. in Govt./ PSU/ Autonomous Body.

Job description :-

Handling of Administration/ Accounts/ Budget, etc. Any other duties assigned by the head of Laboratory from time to time.

B. CDSCO ZONAL/ SUB-ZONAL/ PORT OFFICES

• North Zone, Ghaziabad
• South Zone, Chennai
• East Zone, Kolkata
• West Zone, Mumbai
• Hyderabad Zone
• Ahmedabad Zone
• Chandigarh SubZone
• Bangalore SubZone

(a). Technical Data Associate @ Rs. 17,270/-p.m.

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 manufacturer/ testing of drugs/drugs regulatory affairs.

Job Description

To compile and analyse legal/ scientific data for licensing / approval of CLAA items, BA/BE studies, public testing Laboratories. Documentation, creation and maintenance of National Data Bank. Any other duties assigned by head of the office from time to time.

(b). Data Entry Operator @ Rs.7700/-p.m.

Qualification: The Candidates should be Graduate with 1 year Diploma in computers from recognized Institute. The candidates should have typing speed of 40 w.p.m. Preference will be given to candidates also having short hand knowledge.

Job description :-

Typing of various letters , approvals, licenses, Noting etc. alongwith documentation, Creation & maintenance of National Data Bank. Any other duties assigned by head of the office from time to time.

(C).Office Assistant @ Rs.4,840/-p.m.

Qualification: The candidates should be 12^th pass.

Job description :-

To help technical staff in daytoday work including movements & maintenances of files, record keeping, dak distribution etc. Any other duties assigned head of the section/division from time to time.

C. PORT OFFICES OF CDSCO

• Mumbai Sea/ Air Port
• Nava Sheva Sea Port
• Chennai Port
• Kolkata Port
• IGI Air Port New Delhi

(a) Technical Data Associate @ Rs. 17,270/-p.m.

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 manufacturer/ testing of drugs/drugs regulatory affairs.

Job Description

To compile and analyse legal/ scientific data alongwith Bills of Entry or Shipping Bills for Import , Export of Drugs. Documentation, creation and maintenance of National Data Bank. Any other duties assigned by head of the office from time to time.

(b), Data Entry Operator @ Rs.7700/-p.m.

Qualification: The Candidates should be Graduate with 1 year Diploma in computers from recognized Institute. The candidates should have typing speed of 40 w.p.m. Preference will be given to candidates also having short hand knowledge.

Job description :

Typing of various letters, approvals, licenses, Noting etc. alongwith documentation, Creation & maintenance of National Data Bank. Any other duties assigned by head of the office from time to time.

D. LABORATORIES

• RDTL, Guwahati
• RDTL Chandigarh
• CDTL Chennai
• CDTL Mumbai
• CDL Kolkata
• RDTL Hyderabad

(a). Bench Chemist @ Rs. 17,270/-p.m.

Qualification: B.Pharmacy or Master Degree in chemistry/ Microbiology. The candidates should also have sound knowledge of computer operation. Candidates having experience in testing of drugs will be given preference.

Job Description

To assist in analyst in analysis of Drugs and entry & management of data and correspondence related to it. Documentation, creation and maintenance of National Data Bank. Any other duties assigned by the head of Laboratory from time to time.

(b.) Data Entry Operator @ Rs.7700/-p.m.

Qualification: The Candidates should be Graduate with 1 year Diploma in computers from recognized Institute. The candidates should have typing speed of 40 w.p.m. Preference will be given to candidates also having short hand knowledge.

Job description :-

Typing of various letters, test reports, noting etc. alongwith documentation, Creation & maintenance of National Data Bank. Any other duties assigned by the head of Laboratory from time to time.

(c). Office Assistant @ Rs.4840/-p.m.

Qualification: The candidates should be 12^th pass.

Job description :-

To help analyst /Bench Chemist in daytoday work including cleaning of apparatus/ Equipments etc. Any other duties assigned by the head of Laboratory from time to time.

(d). Account Officer @ Rs. 19,250/-p.m.,

Qualification:

Graduate with 5 years experience in Accounts & Finance. in Govt./ PSU/ Autonomous Body. Preference will be given to Commerce Graduate having above experience.

Job description :-

Handling of Accounts. Budget, Preparation of Bills, Payment of Salary etc. Any other duties assigned by the head of Laboratory from time to time.

(e). Technical Consultant @ Rs.19,250/-p.m.

Qualification:

(i) M. Pharma with 1 year experience in testing of drugs. The candidates should also have sound knowledge of computer operation.

Job description:-

Shall be responsible for maintenance of Data Base of all the activities in Laboratory. Development of SOPs guidelines, Documentation, inventory assessments etc. Any other duties assigned by the head of Laboratory from time to time.

(f). Admin/ Financial Consultant @ Rs. 19,250/-p.m.,

Qualification:

Graduate with 5 years experience in Administration / Finance. in Govt./ PSU/ Autonomous Body.

Job description :-

Handling of Administration/ Accounts/ Budget, etc. Any other duties assigned by the head of Laboratory from time to time.

DESIRABLE QUALIFICATION/SKILLS

FOR ALL THE ABOVE POST EXCEPT FOR OFFICE ASSISTANT THE

APPLICANTS ARE EXPECTED TO BE PROFICIENT WITH USE OF COMPUTER

AND INTERNET.

Note :-

A soft copy of application may be sent by email to the undersigned at drvgsomaniddci@gmail.com for information.

Encl.:Proforma for Application

(Dr. V.G Somani) Dy. Drugs Controller (I)