
Clinical Quality Assurance Specialist
1 week ago
Overview:
We are seeking an experienced professional to oversee quality compliance and assurance within our clinical research department. This role will be responsible for ensuring that all clinical trial activities meet the highest standards of quality, safety, and regulatory compliance.
Key Responsibilities:
- Oversee end-to-end clinical trial activities from a quality perspective
- Ensure adherence to applicable regulations and guidelines
- Develop and implement risk-based approaches to quality compliance
- Identify and decide team member's job specific SOP training requirements
- Preparation of SOPs related to QC function
Requirements:
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
Good conflict management skills
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
Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards
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