BRIC-Translational Health Science and Technology Institute (THSTI) is an Institute of the Biotechnology Research and Innovation Council, Department of Biotechnology, Ministry of Science & Technology, Govt. of India. The institute is an integral part of the interdisciplinary NCR Biotech Science Cluster located at Faridabad, and is designed as a dynamic, interactive organization with the mission to conduct innovative translational research and to develop research collaborations across disciplines and professions to translate concepts into products to improve human health.
Applications are invited from eligible candidates to fill up the following positions
Post : Quality Manager (01 Position)
Name of the Study : DTRC
Age : 45 years
Emoluments : Rs 80,000/-
Duration : Upto Feb 2025
Minimum Educational Qualification and Experience :
• Master's Degree or PG Diploma in Life Sciences or Biomedical Sciences or Pharmacy or Public Health or Clinical Research.
• At least 4 years of demonstrated experience in clinical trial monitoring or clinical site management experience.
• GCP Certification.
Desirable :
• GCLP Certification or experience of monitoring of laboratory-based activities/ research.
• Two years of work experience in the area of Quality Control and Quality Assurance in clinical research.
Job profile
• Oversees quality management processes and provides guidance and support to project teams to meet quality standards.
• Actively lead or assist activities in the areas of Internal Quality improvements and CAPA (Corrective and Preventive Actions).
• Ensure that the assigned study is conducted in accordance with study protocols, GCP guidelines, and applicable regulatory requirements.
• Lead or assist with identifying non-conformances with requirements, provide suitable recommendations, and facilitate ongoing quality improvements using a risk-based methodology.
• Proactively identify the project risks and assist in providing training to study staff in good clinical and documentation practices.
• Maintain GCP-compliant processes that control the quality of work at the study site.
• Conduct source document verification and case record forms for assessing the study trends.
• Develop quality monitoring plan and processes for clinical activities of data collection, laboratory-based activities of sample processing and storage, and running of the biorepository.
• Overseeing and/or performing quality functions and executing quality programs (clinical operations, clinical laboratory, data management review)
• Collaborate with clinical and project management teams to ensure compliance with quality standards, timelines, and appropriate follow-up in areas of deficiency.
• Coordinate expert monitoring visits/ audits as per project requirements.
• Work with the Clinical Portfolio Management department and other internal departments on their requirements as and when required.
• Work with data management and other key departments (laboratory, etc.) to track the process, and progress, and to ascertain the foreseen challenges proactively.
Skills
• Good understanding of needs for projects and job responsibilities.
• Extensive knowledge of GCP/GLP, observational studies, and appropriate regulations and guidelines.
• Ability to develop and implement clinical and laboratory monitoring plans, SOPs, database concepts, and formats.
• Ability to build effective project teams, ability to motivate others, delegate, drive, and timely/ quality decision-making.
• Operational skills including focus and commitment to quality management and problem solving.
• Influencing skills including negotiation and teamwork.
• Effective communication skills to provide timely and accurate information to all stakeholders.
• Ability to assess non-compliance situations and recognize the potential or real wider strategic risk to the project, escalate when needed.
• Ability to identify systematic causes of complex quality problems and recommend long-term solutions.
• Create fair and ethical culture that fosters high standards of ethics.
• Basic business computer skills (MS Word, Excel, e-mail).
General Terms & Conditions
a) This is short-term positions and extension will be granted subject to satisfactory performance of the incumbents and tenure of the project for which they are selected. Those appointed to these positions will not have any claim for regularization of their employment.
b) All educational, professional and technical qualification should be from a recognized Board/University.
c) The experience requirement specified above shall be the experience acquired after obtaining the minimum educational qualifications specified for the post.
d) The age limit, qualification, experience and other requirements may be relaxed at the discretion of the competent authority, in case of candidates who are otherwise suitable.In case candidates are not found suitable for the posts notified, they can be offered lower post / lower emoluments on the recommendation of the Selection Committee.
e) Age and other relaxations for direct recruits and departmental candidates: 1. By five years for candidates belonging to SC/ST communities. 2. By three years for candidates belonging to OBC communities. 3. For Persons with Benchmark Disabilities (PWBD) falling under the following categories: (i) UR - ten years, ii) OBC - 13 years (iii) SC/ST - 15
4. Age is relaxable for Central Government servants up to five years in accordance with the instructions or orders issued by the Central Government, from time-to-time. 5. There is no upper age limit for the Institute employees who are treated as departmental candidates. 6. For Ex¬servicemen up to the extent of service rendered in defense forces (Army, Navy & Air force) plus 3 years provided they have put in a minimum of 6 months attested service.
f) All results will be published on our website and all future communications will be only through email.
g) In case a large number of applications are received, screening will be done to limit the number of candidates to those possessing higher/relevant qualification and experience.
h) With regard to any provisions not covered in this notification, the bye laws of THSTI / Govt. of India rules / guidelines shall prevail.
i) Canvassing in any form will be a disqualification.
j) You are requested to bring 2 passport size photograph & one set of photocopies of your education/qualification certificate/documents along with the originals at the time of interview "Government strives to have a work force which reflects gender balance and women candidates are encouraged to apply"
Interested candidates fulfilling the criteria as mentioned may walk-in for a written test/skill test / interview on 14th October @10:00 at THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad - 121001. (Note - The candidate must report by 09:30 AM to be interviewed otherwise the candidate will not be interviewed by the selection committee).
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