Career for Pharma, Life Sciences candidate as QA Consultant at THSTI - Salary Rs. 1,50,000 pm

This recruitment is to fill up the vacancies for project positions at Clinical Development Services Agency (CDSA) center. CDSA is a niche center of THSTI established to facilitate development of affordable healthcare products for public health diseases. It is the only public Centre in the country created with a mandate to support and nurture cost-effective, high quality, not-for-profit technology-based preclinical and clinical product development as well as support clinical research conducted by public agencies. It works towards development of an eco-system for training and learning and work with public sector institutions, and small and medium enterprises (SME) to translate innovative technologies into medical products for public good.

Post : Consultant - Quality Assurance (Clinical Research)

Emoluments : Rs. 1,50,000/-
Age : Upto 45 years
Essential qualification and work experience :
• Doctorate in life sciences or biomedical sciences or Pharmacy or Clinical Sciences OR Master’s degree in life sciences or biomedical sciences or pharmacy or public health or clinical research OR MBBS/ BDS/ BHMS/ BAMS/ BPT/BVSc (Experience as above).
• WITH at least 5 years of demonstrated experience in the area of Quality Control, Quality Assurance in clinical research and GCP/ GCLP trained and certified.

Desirable :
• Auditing and Inspection experience preferred
• Proven track record of managing quality systems in clinical trials and laboratory settings.
• Hands-on experience with regulatory inspections and audit readiness.
• Strong understanding of Indian regulatory guidelines (DBT, ICMR, CDSCO) and International GxP standards.
• Experience of monitoring of laboratory-based activities/research.
• Proven experience in team leadership and people management.
• Familiarity with global regulatory framework like EMA, FDA and WHO.
• Knowledge of QA tools.

Job profile
The Sr. Manager - Quality Assurance (Clinical Research) will oversee and drive quality management activities across CDSA-supported clinical research and laboratory operations. This role ensures that all the CDSA processes adhere to the applicable regulations and institutional standards, and contribute in the overall process improvement are implemented in a risk-based framework. Clinical Research Quality Management
• Lead or support internal quality improvement initiatives and CAPA processes, identifying non-conformances and facilitating risk-based corrective actions.
• Review the Quality Monitoring Plan, Data Management Plan, Statistical Analysis Plan, Safety Management Plan etc.
• Conduct internal and external audits of clinical sites, laboratories, and other relevant areas to assess compliance with regulations, protocols, and institutional procedures.
• Evaluate the quality systems, identify areas for improvement and ensure adherence to quality standards.
• Ensure all clinical research activities are conducted in compliance with applicable regulatory requirements (e.g., GCP, FDA, EMA) and institutional SOPs.
• Monitoring and assessing data quality and integrity throughout the clinical research process and provide real-time quality advice. • Developing and maintaining Standard Operating Procedures (SOPs) for all aspects of QA functions and reviewing SOPs of various functions under CDSA.
• Collaborating with internal team, vendors, sponsors and other stakeholders to ensure quality and compliance.
• Preparing for and participating in regulatory inspections (e.g., CDSCO, FDA, EMA) and sponsor audits.
• Managing the overall quality assurance program, including staff, processes, and continuous improvement initiatives.
• Coordinate and participate in monitoring visits, audits and inspections (internal and external), and manage follow-up on findings.
• Review and provide guidance on study-related documents (protocols, CRFs, manuals, training materials) to ensure consistency with protocol and regulatory requirements.
• Collaborate with internal team members to track milestones, timelines and emerging quality risks.
• Provide QA support during both study start-up and close out ensuring proper documentation.

Laboratory Quality Oversight
• Provide oversight and guidance to CDSA staff and investigators on laboratory quality matters for ongoing studies.
• Provide guidance on and contribute to laboratory training sessions for ongoing studies, including workflow evaluations of phlebotomy and sample transport, etc.
• Review site-specific SOPs for sample collection, processing and handling; provide guidance and feedback to site teams.
• Oversee quality assessments at central laboratories, ensuring harmonized standards.
• Ensure GCLP compliance for overall study conduct.

Systems and Documentation
• Establish and maintain QA procedures and document control systems across all CDSA functions (clinical operations, laboratory activities, data management, regulatory affairs, etc.).
• Ensure all standard operating procedures, work instructions, and quality records are updated promptly and distributed to relevant stakeholders.
• Implement robust version control for all SOPs and critical documentation to track changes and maintain document integrity
• Support development and implementation of electronic quality management systems and tools (e-QMS).
• Generate periodic quality metric reports and present to senior leadership for continuous improvement.
• Ensure system validation of different electronic systems used by CDSA like CTMS, CDMS etc

Cross-Functional Collaboration
• Establish and lead a cross-functional Quality Oversight Forum with clinical operations, laboratory, data-management and regulatory teams to review key metrics, oversee CAPA implementation and drive continuous improvement.
• Act as the primary QA liaison between CDSA (Clinical Portfolio Management, Data Management), THSTI (Laboratory, Regulatory Affairs) and external partners to ensure alignment on quality standards and deliverables.
• Lead proactive risk management, identifying potential quality issues early, coordinating root-cause analyses and deploying mitigation strategies.
• Embed QA expertise in protocol development, study plan, CRF design and study-specific logs and forms and other governance forums to safeguard compliance at every stage.
• Faculty for MSc (Clinical research) and PG Diploma in regulatory science course.

Skills/Knowledge/ Aptitude
• Effective communication skills that include the provision of timely and accurate information to stakeholders, proficient in English, strong written and oral communication skills
• Excellent training skills
• Proficiency in quality management software and Microsoft Office suite
• Strong analytical and problem-solving abilities
• Meticulous attention to detail and documentation
• Ability to work collaboratively in multidisciplinary teams
• Demonstrated ability to prioritize workload in order to meet multiple deadlines
• Ability to develop and deliver presentations, prepare technical reports and contribute effectively in the manuscripts

General Terms & Conditions
a) These are the 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. 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 the eligibility criteria.
d) Closing date of online application will be the CRUCIAL DATE for determining eligibility with regard to age, essential qualification, experience etc.
e) 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.
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. 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.
g) All results/notifications will only be published on our website. Therefore, the candidates should essentially visit THSTI website, regularly.
h) All communications will only be made through email.
i) 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.
j) The no. of vacancy indicated above may change subjected to the actual requirement at the time of Written test/skill test/interview.
k) With regard to any provisions not covered in this notification, the bye laws of THSTI / Govt. of India rules/ guidelines shall prevail.
l) Canvassing wrong information in any form will be a disqualification.

1. 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, professional experience / 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 degree/certificate (if applicable)
viii) Relevant experience certificates (if applicable)
ix) Caste / Disability certificate in the format prescribed by the Govt. of India, if applicable
2. Procedure for filling up online application:
i) The eligible and interested candidates may apply online at the Institute’s website. 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
C) Step 3 : Payment of application fee
• The payment can be made by using Debit Card / Credit Card / Internet Banking/ 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.
Unreserved, OBC & EWS candidates : Rs 590/-
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 this regard shall be entertained.
vii) In case of difficulty in filling up the online form, please send e-mail to HR.CDSA@THSTI.RES.IN along with the screenshot of the error displayed (if any).

Last date for receipt of online application for posts : 01 September 2025.