Translational Health Science and Technology Institute (THSTI) is an autonomous Institute of the Department of Biotechnology, Ministry of Science and 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.
Post : Program Officer/T.O-II (01 Positions)
Name of the Program : Good Clinical Practice Professional Certification Scheme (GCPPCS)
Emoluments : Up to Rs. 75,000/-
Age Limit : 55 Years
Minimum Educational Qualification and Experience : • Bachelor’s degree in Medicine/Dentistry/Engineering/Technology, or Master’s degree in Science / Pharma / relevant field from a recognized university;
• Minimum 05 years of relevant industry experience at a mid/senior level in certification and/or conformity assessment activities for clinical/healthcare, pharma, medical devices, and/or related sectors;
• Demonstrated working proficiency or professional ability/understanding in certification schemes and/or standards, and the certification process, preferably management of certification schemes as per ISO standards; Knowledge of requirements of accreditation standards preferably ISO 17024, or other standards such as ISO 17021, and the accreditation process.
Duration : One year
Location : CDSA, THSTI, NCR, Biotech Science Cluster, Faridabad
• Day-to-day management of GCP Professional Certification Scheme which includes but is not limited to both PrCBs (Personnel Certification Bodies) as well as assessment of TIs (Training Institutions)
• Maintaining documentation – as per the requirements of GCPPCS including any changes needed from time to time
• Coordination of any changes or enhancements in the GCPPCS and drafting of necessary documents
• Promotion of GCPPCS for wider acceptance among stakeholders, across the globe
• Overseeing and drafting agreements, Memorandums of Understanding (MOUs), related to the GCPPCS
• Promote GCPPCS among Personnel Certification Bodies and Training Institutes
• Contribute as a resource person and represent THSTI in national & international forums on GCPPCS.
• Create awareness about the GCPPCS first-in-globe launched by THSTI across the nation through the websites, social platforms, and other outreach avenues.
• Work towards making the GCPPCS professionals with unmatched quality and credibility
• Develop and maintain client relationships and endeavour to meet client expectations (internal & external)
• Sound technical knowledge, and interdisciplinary approach to scientific research
• Excellent management, inter-personal, & networking skills
• Excellent communication skills, both verbal & writing
• Proficient in computers and other IT skills
• Ability to prepare concept notes & policy documents
• Ability to manage quality systems documentation
• Ability to promote and expand GCPPCS
Desirable qualifications & Work experience
• Lead auditor training in any certification standard and/or Assessor training in any accreditation standard;
• Sectoral/regulatory knowledge relevant to clinical practices;
• Knowledge of Good Clinical Practice Professional Certification Scheme, or having knowledge/experience in any other relevant/similar certification scheme;
• Professionals having experience in certification schemes/ audits or working with certification bodies will be preferred;
• Experience in certification of professionals and/or training courses/institutions
GENERAL TERMS & CONDITIONS:
a) The positions is short-term basis with a probation period of three months. The 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) Closing date of online application will be the CRUCIAL DATE for determining eligibility with regard to age, essential qualification etc.
e) The 01 position to be hired, 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.
f) 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.
g) All results will be published on our website and all future communications will be only through email h) 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. i) With regard to any provisions not covered in this notification, the bye laws of THSTI / Govt. of India rules / guidelines shall prevail.
j) Canvassing wrong in any form will be a disqualification.
HOW TO APPLY :
Documents to be kept handy before filling up the online application: all the documents except (i) should be in pdf format: -
i) A soft copy of your passport size photo and signature. (jpeg/jpg/png format)
ii) A comprehensive CV containing details of qualification, positions held, professionalexperience / distinctions etc.
iii) Matriculation certificate (equivalent to 10th Standard) / Mark sheet)
iv) Intermediate certificate (equivalent to 12th Standard) / Mark sheet)
v) Graduation/Diploma degree certificate / Mark sheet
vi) Post-Graduation degree certificate & Mark sheet (if applicable)
vii) PhD/MD Degree (if applicable)
viii) Relevant experience certificates (if applicable)
ix) Caste / Disability certificate in the format prescribed by the Govt. of India, ifapplicable.
PROCEDURE FOR FILLING UP ONLINE APPLICATION:
i) The eligible and interested candidates may apply online at the Institute’s website thsti.res.in/career. Applications through any other mode will not be accepted. ii) The following will be the step wise procedure-
A) Step 1 : Details of applicant
B) Step 2 : Uploading of documents
3 : Payment of application fee
• The payment can be made by using Debit Card / Credit Card / InternetBanking / UPI.
• Once payment is made, no correction / modification is possible
• Candidates are requested to keep a copy of the provisional receipt for future reference.
• Fee once paid shall not be refunded under any circumstances.
• Details of fees to be paid are as shown below :
1. Unreserved, OBC & EWS candidates : Rs 590/-
2. SC/ST/Women/PwBD : Rs 118/-
D) Step 4 : Submission of application form
iii) On successful submission of application, an auto-generated email containing the reference number will be sent to the email address provided. Please keep a note of the reference number for future correspondence.
iv) Candidates are required to keep a printout of the online application form by using the print button on the dashboard for future reference.
v) Candidates must ensure that he / she fulfils all the eligibility criteria as stipulated in the advertisement. If it is found that he / she does not fulfil the stipulated criteria during the recruitment process, the candidature of the candidate will be cancelled. If the same is noticed after the appointment, the candidate will be terminated following due process.
vi) Incomplete applications shall be summarily rejected and no correspondence in thisregard shall be entertained.
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