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

Project : “Translation Research Consortium for Establishing Platform Technologies to Support Prophylactic and Therapeutic Strategies for Dengue Discovery to Proof-of-Concept”

Emoluments : Up to Rs.90,000/-

Duration : The study duration is four years. The initial appointment will be for a period of one year to be continued subject to performance.

Age : Up to 45 years

Job profile
• Actively lead or assist activities in the areas of Internal Quality improvements and CAPA (Corrective and Preventive Actions).
• Ensure that 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 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 which 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 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 Clinical Portfolio Management and other internal departments on their requirements as and when required
• Work with data management and other key departments (Laboratory) to track the process, progress, and to ascertain the foreseen challenges proactively

Qualifications and Experience
Master’s degree in life sciences or biomedical sciences or pharmacy or Public Health or Clinical Research. 5 years of demonstrated experience in the area of Quality Control, Quality Assurance and Clinical operations. GCP/ GLP trained and experience of handling observational studies will be preferred. The candidate must demonstrate experience of having done monitoring of laboratory based activities.

Skills
• Good understanding of needs for project 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, 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.
• Basic business computer skills (MS Word, Excel, e-mail)

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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
• Caste certificate in the format prescribed by the Govt. of India, if applicable
• 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 mahendersingh.cdsa@thsti.res.in
e. On successful submission of your application, a pop up window will appear showing the reference number. Please keep a note of the reference number for future correspondence.