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Recruitment for Quality Manager (Project Position) at Clinical Development Services Agency (CDSA), THSTI-Walk-in on 16th September 2025

CDSA
Pharmacareer

Website CDSA

About CDSA

The Clinical Development Services Agency (CDSA), a specialized center of Translational Health Science and Technology Institute (THSTI), was established to drive affordable healthcare innovations for public health diseases. It is India’s only public sector center mandated to support not-for-profit, cost-effective, high-quality preclinical and clinical product development. CDSA collaborates with public sector institutions and SMEs to translate innovative technologies into impactful medical solutions while also building capacity through training and learning initiatives.

Position Details

  • Post: Quality Manager (Project Position)

  • Project: Effects of extreme heat on maternal, placental and fetal physiology, lactation and newborn health in India

  • Location: Gurugram Civil Hospital (GCH) & THSTI

  • Emoluments: ₹87,000/- per month (consolidated)

  • Age Limit: Up to 45 years

Essential Qualifications & Experience

Candidates must possess:

  • Option 1: MBBS, BDS, BVSc, BAMS, BHMS, BUMS, BSMS, BNYS, B.Sc. Nursing, BPT, B.Pharm with minimum 4 years of experience in clinical trial monitoring or clinical site coordination/management.

  • Option 2: Graduate degree in Life Sciences/Biomedical Sciences/Public Health with minimum 6 years of similar experience.

  • Option 3: Postgraduate degree or Ph.D. in Life Sciences/Biomedical Sciences/Pharmacy/Public Health with minimum 4 years of relevant experience.

  • Must hold a valid GCP certification.

Desirable:

  • At least 2 years of work experience in Quality Control/Quality Assurance in clinical research.

Key Responsibilities

  • Oversee quality management processes across project sites and provide guidance to ensure compliance.

  • Conduct site monitoring visits (initiation to closeout) in line with GCP and regulatory requirements.

  • Lead internal quality improvements and manage CAPA (Corrective and Preventive Actions).

  • Identify non-conformances, recommend corrective measures, and drive continuous quality improvement.

  • Train site staff on GCP and documentation practices.

  • Develop SOPs, quality monitoring plans, and checklists for clinical and laboratory activities.

  • Manage essential documents throughout the trial duration.

  • Collaborate with clinical, project management, and laboratory teams to ensure adherence to standards.

  • Coordinate expert monitoring visits and audits as required.

  • Travel frequently across study sites as per project needs.

Required Skills

  • Strong knowledge of GCP/GLP, observational studies, and regulatory guidelines.

  • Ability to develop and implement SOPs, quality monitoring plans, and compliance processes.

  • Effective leadership, delegation, and decision-making skills.

  • Strong communication and influencing skills for stakeholder engagement.

  • Analytical skills to assess non-compliance, identify risks, and propose long-term solutions.

  • Proficiency in MS Office (Word, Excel, Email).

General Terms & Conditions

  • Appointment is purely temporary and project-based; no claim for regular employment.

  • Extension will depend on project requirements and performance.

  • Relaxations in age/qualification/experience may apply as per Govt. of India rules.

  • Number of vacancies may vary based on project needs.

  • Results and notifications will be published only on the THSTI website.

  • Canvassing or furnishing false information will lead to disqualification.

Selection Process

  • Mode: Walk-in for written test/skill test/interview

  • Date & Time: 16th September 2025 at 9:00 AM

  • Venue: THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad–Gurugram Expressway, Faridabad – 121001

Note:

  • Candidates must bring:

    • Latest resume

    • One set of photocopies of educational & experience certificates (with originals for verification)

    • Valid ID proof

  • Candidates arriving after the reporting time will not be entertained.

  • Mobile phones must be deposited at the reception during the selection process.