Clinical Development Services Agency (CDSA) is an extramural unit of Translational Health Science and Technology Institute (THSTI) and has been established as a not-for-profit society to provide cost affective, high quality preclinical and clinical product development support services to meet the country’s growing healthcare needs. It will tend enterprises; particularly SMEs involved in new technology innovation and facilitate translation of scientific know-how into viable products.
Post : Quality Manager, DTRC Project, CDSA
Project : Translation Research Consortium (TRC) for establishing platform technologies to support prophylactic and therapeutic strategies for dengue discovery to proof-of-concept”
Emoluments : Up to Rs. 1,00,000 per month
Duration : Full time position. Program duration is three years The initial appointment will be for a period of one year to be continued subject to performance.
Age : Up to 45 years (Flexible for exceptional candidates)
Lead person for laboratory quality assurance of the program and nodal point for investigators of participating institutes and the funding agency for the lab related study activities
• Oversees quality management processes and provides guidance and support to project teams to meet quality standards for sample collection, laboratory processing, shipment, storage.
• Develop a laboratory quality management program in collaboration with investigators, develop/ review reports/ checklists, training material and related documents for lab related activities
• Define and maintain QA/QC objectives, targets, and processes and review new targets, processes, supplies, and technologies for quality standards.
• Develop, implement, communicate, and maintain system and procedures, monitor the QA/QC procedures of all the laboratories by gathering relevant data.
• Develop quality monitoring plan and processes for clinical activities of data collection, laboratory-based activities of sample processing and storage and storage at biorepository.
• Maintain GCP/GCLP compliant processes which control the quality of work at the study site.
• Actively support the investigators in the all areas of quality utilizing best global practices and quality risk management.
• Support for quality audits for Labs, follow-up on recommendations, and initiate corrective or preventative actions, when appropriate.
• Review the Levy-Jennings QC chart for all the laboratory parameters and results obtained from proficiency testing and from the external quality system
• Lead or assist with identifying non-conformances, conduct RCA, provide suitable recommendations (CAPA), check CAPA effectiveness.
• Identify quality indicators, facilitate ongoing quality improvements using risk-based methodology, conduct and report continual improvement.
• Conduct trend analysis and take requisite action.
• Collaborate with NBM, Investigators and project management team to ensure compliance with quality standards, timelines and appropriate follow-up in areas of deficiency
• Coordinate expert monitoring visit/ audits as per project requirement.
• Work with data management and other key departments (like clinical portfolio management) to track the process, progress, and to ascertain the foreseen challenges proactively and address and report them.
Qualifications and Experience
Essential: • S/he should have MD (Microbiology/ Biochemistry/ Pathology)/ PhD. in relevant discipline with at least 3 years of demonstrated experience in laboratory (clinical/ research) quality assurance with hands-on exposure of QC, QA and laboratory operations in research setting
• OR Diploma in Clinical Pathology/Microbiology/ Biochemistry or a Masters in similar fields with at least 5 years of demonstrated experience in laboratory (clinical/ research) quality assurance with hands-on exposure of QC, QA and laboratory operations in research setting
• Proven experience of clinical research (GCP), and/ or laboratory (GCLP, NABL standards, etc.). Desirable:
• Demonstrate experience of having monitoring of laboratory-based activities for research program
• Trained and experience of working on observational studies / large cohort studies.
• Good understanding of project and job responsibilities.
• Good knowledge of GCP/GCLP, research studies and applicable 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, delegation, 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 stakeholders
• Ability to assess non-compliance situations and recognize potential or real wider strategic risk to project, escalates when needed.
• Ability to identify systematic causes of complex quality problems and recommend long-term solutions
• Fair and ethical. Creates a culture that fosters high standard of ethics.
• Advanced business computer skills (MS PPT, MS Word, Excel)
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 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.
8. This position is strictly project-based.
9. All results will be published on our website and all future communications will be only through email
10. Candidates (Including SC/ST and other backward classes) are not entitled for the travel reimbursement or any other reimbursement for attending the interview.
11. This position will be placed in CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad.
12. Canvassing in any form will be a disqualification.
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) The documents in support of educational qualification and experience (PDF format only, file size 1 mb maximum) as mentioned below:
* Matriculation Mark sheet
* Intermediate Mark sheet
* Graduation Degree/Mark Sheet
* Post-Graduation Degree/Mark Sheet
* Ph.D. degree
* Relevant experience certificates
* Disability certificate in the format prescribed by the Govt. of India, if applicable
* List of Publications (if any)
* List of patents (if any)
b. Candidates are requested to use Google Chrome internet browser for best results in submission of online application.
c. Once online application is submitted, no correction/ modification is possible.
d. In case of difficulty in filling up the online form, please send an e-mail to firstname.lastname@example.org
e. On successful submission of your application, an auto-generated email containing a reference number will be sent to the email address provided. Please keep a note of the reference number for future correspondence.
Last date for receipt of online application is 31st Oct 2020
Note : 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.
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