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.
Post : Quality Manager (01 Position)
Name of the Study : Translational Research consortium for Establishing Platform Technologies to support Prophylactic and Therapeutic Strategies for Dengue Discovery to Proof-of - Concept (Dengue TRC)
Age : 45 years
Emoluments : Rs 80,000/-
Minimum Educational Qualification and Experience : Essential qualification and work 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 “Government strives to have a work force which reflects gender balance and women candidates are encouraged to apply” 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. The candidates are required to satisfy themselves, before applying /appearing for the selection process, that they possess the minimum eligibility criteria as laid down in the recruitment advertisement. No query will be entertained with regard to eligibility criteria.
d) Closing date of online application will be the CRUCIAL DATE for determining eligibility with regard to age, essential qualification etc. 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. Institute employees will get the age relaxation to the extent of the service rendered by them as on closing date of advertisement. 6. For Ex-servicemen upto the extent of service rendered in defence forces (Army, Navy & Air force) plus 3 years provided they have put in a minimum of 6 months attested service
e) All results will be published on our website and all future communications will be only through email.
f) 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.
g) The no. of vacancy indicated above may change subjected to the actual requirement at the time of Written test/skill test/interview 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.
Interested candidates fulfilling the criteria as mentioned for the above positions may walk-in for a written test/skill test/interview on 17th December 2024 @10:30 AM at BRIC-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).
Note : The candidates must bring their latest resume, one set of photocopy of documents in support of their educational qualification and experience along with originals and a valid ID card for verification. Candidates coming after the time slot mentioned will not be entertained.
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