Clinical Quality Assurance and Regulatory Affairs Specialist

3 days ago


Bhavnagar, Gujarat, India beBeeQualityCompliance Full time ₹ 1,20,00,000 - ₹ 2,00,00,000
Job Description

This role oversees end-to-end clinical trial activities from a quality perspective. The incumbent will be accountable for ensuring 24x7 Inspection/audit readiness through rigorous review of all study related activities, processes, and procedures. They must ensure adherence to applicable regulations and guidelines.

The ideal candidate will develop and implement a risk-based approach to Quality Compliance (QC) within the function. This will involve identifying and deciding team member's job specific SOP training requirements, preparing SOPs related to QC function, and supporting the review of SOPs specific to Medical science, Clinical team, and Data Management team.

Additionally, the incumbent will be responsible for quality review of clinical trial medical science related activities like Synopsis, Protocol, Clinical Study Report (CSR), and appendices. They will also conduct quality reviews of clinical trial operation related activities, including site feasibility, site selection visit, site initiation, Ethic committee documentation, monitoring – site specific reports, Site Documents, logs, and close out activities.

Required Skills & Qualifications
  • 5 years' experience in a CRO/Pharma/Biotech organization in Quality department with experience of Quality activities in Clinical Research department.
  • Strong eye for detail and ability to spot inconsistencies a must and good conflict management skills.
  • Must have experience in handling audits & inspections of DCGI, US FDA.
  • Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations, and other applicable regulations pertaining to clinical trials.
  • Experience of working in matrix business environments preferred.
What We Offer

We offer a challenging and rewarding career opportunity that is designed to foster growth and professional development. As a valued member of our team, you will enjoy a competitive salary, excellent benefits package, and opportunities for professional advancement.



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