Translational Health Science and Technology Institute (THSTI) is an autonomous Institute of the Department of Biotechnology (DBT), Ministry of Science and Technology, Govt. of India. The institute is an integral part of the interdisciplinary NCR Biotech Science Cluster (NCR BSC) located at Faridabad, and is designed with the mission to conduct innovative translational research to translate concepts into products to improve human health.
Post : Quality Assurance Manager (1)
Name of the Study : Mission COVID Suraksha (NBM Project)
Emoluments : Maximum up to Rs 40,000/- per month
Duration : One year (To be extended as per the requirement of the Project)
Age Limit : Upto 40 Years
Location : CDSA, THSTI, NCR, Biotech Science Cluster, Faridabad
This position is responsible for conducting quality assurance activities during the study conduct to ensure that the participating sites follow clinical trial processes and that quality standards are met for the trials. The QA manager will ensure compliance with existing procedures, protocol and applicable regulatory requirements. He/ She will be responsible for identifying and escalating non-compliances to the expected quality practices of documentation and execution that are associated with clinical research or trial activities to the program manager CDSA, the project co- ordinating team CDSA and the sponsor. He/ She will also support the sponsor for preparing for any internal and external quality audits. The quality manager, if required, will also be responsible for conducting quality assurance activities to ensure the study and regulatory requirements compliance of other collaborators/ stakeholders contributing to the clinical trials:
• Ensure compliance with existing procedures, protocol and applicable regulatory requirements.
• Assure quality standards are met and will be responsible for assuring facilities, equipment and processes are properly validated.
• Provide feedback and develop systems to ensure compliance.
• Conduct audits (retrospective, in-process, systems, and process/horizontal) in area relating to clinical studies.
• Efficiently partner with Program Managers for purpose of identifying non-compliance and quality issues.
• Assess audit finding from internal and external quality audits, and provide periodic assessing root causes and compliance feedback with future follow-up to Program Manager/ head of CPM and the sponsor.
• Ongoing review of local procedures and practices for maintenance identify and/or lead improvement efforts to enhance the consistency of study management activities (those internal and external) throughout the clinical study relative to current processes, regulatory guidelines, and/or quality (including Global and Local SOP,s, ICH, GCP. DCGI, etc)
• Host/facilities audits by Sponsors/clients and inspections by Regulatory Authorities.
• Provide leadership, training and mentoring to QA personnel.
Qualifications and Experience
(i) Bachelor’s degree or equivalent in a biomedical field. Post Graduate Diploma or a Master’s degree in a biomedical field will be preferable
(ii) Minimum of 6-8 years of experience in conducting Quality Assurance activities and audits in clinical trials domain. Previous experience with vaccine trials will be preferred.
Desirable:- Certification in QA processes. Skills
• Must have a demonstrated understanding of drug development and conduct of regulatory trials.
• Well- developed interpersonal communication skills both verbal and written Strong client focus.
• Good organizational skills with ability to prioritize
• The ability to do multi-task and problem solve
• Must have a demonstrated ability to successfully manage multiple projects and cross-functional teams
• Must be flexible to adapt to and manage change
GENERAL TERMS & CONDITIONS:
1. All educational professional and technical qualification should be from a recognized Board / University and full-time.
2. The experience requirement specified should be experience acquired after obtaining the minimum educational qualifications required for the post.
3. Persons working in Govt. or Public Sector undertaking should produce “No Objection Certificate” at the time of Interview.
4. The qualification, experience and the number of position and other requirements for the post can be relaxed at the discretion of the Chairman of the Interview Committee, in case candidates are otherwise well qualified.
5. Only shortlisted candidates will be contacted for interview
6. Incomplete applications will stand summarily rejected without assigning any reasons
7. The salary is a consolidated sum as per sanctioned order without any other benefits. Salary mentioned against the position is the maximum and can be lesser based on candidate’s experience, qualifications, skill set, etc. A 10% annual increase in salary is based on the performance 8. This position is strictly project-based.
9. This position may require 25% or more travel.
10. All results will be published on our website and all future communications will be only through email
11. Candidates (Including SC/ST and other backward classes) are not entitled for the travel reimbursement or any other reimbursement for attending the interview.
12. This position will be placed in CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad.
13. Canvassing in any form will be a disqualification.
14. Submission of application will be thru online mode only otherwise it will get rejected or ignored.
Procedure for filling online application:
a. Before filling up the online application, keep the following documents handy:
i) A soft copy of your passport size photo and signature. (only jpeg/jpg format, file size 50 kb maximum)
ii) A comprehensive CV (PDF format only, file size 1 mb maximum) containing details of qualification, positions held, professional experience/distinctions etc.
iii) a) Candidates are requested to use Google Chrome internet browser for best results in submission of online application.
b) Once online application is submitted, no correction/ modification is possible.
c) In case of difficulty in filling up the online form, please send an e-mail to firstname.lastname@example.org
d) Those who have applied once need not to apply again.
e) Only technical queries will be resolved (if any), other than technical will be rejected and ignored.
f) On successful submission of your application, a pop-up containing a refereal application number will come on your screen.
Note : This is a rolling out advertisement on CDSA website only. The application will be screened on weekly basis. In case a suitable candidate is not found, the call for application will remain open till suitable candidate is found. As soon as suitable candidate is found, this recruitment notice will be closed on our website.
“Government strives to have a work force which reflects gender balance and women candidates are encouraged to apply”
Recruitment Notice No. CDS/RN/3.1/2021
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