Specialist - Clinical DQA

Job Description:

Responsibilities

• Plan and perform vendor qualification and audits for pre-clinical, clinical, and In-vitro studies service providers
• Post study audit (off-site and on-site) of Pre-clinical, Bioequivalence studies and Clinical studies.
• Maintain and update the Quality Management System for Global Clinical Management
• Develop, review, and approve SOPs for pre-clinical, clinical, and QA processes
• Execute Clinical audit programs and support health authority inspections
• Review regulatory deficiencies and support cross-functional teams in preparing responses
• Analyse deviations, incidents, and root causes, implementing corrective and preventive actions for clinical studies
• Self-Inspection of Global Clinical Management team
• The ideal candidate will have a strong background in GCP, GLP, and quality management processes, with the ability to work efficiently in a fast-paced environment.

Qualification & Experience   

• Master's degree in Pharmacy or Clinical research
• 8-12 years of experience in clinical quality assurance or related field
• Strong proficiency GCP and GLP
• Hands-on experience with bioanalytical analysis
• Proven track record of working with large-scale data sets and data warehousing
• Excellent understanding of data governance principles
• Knowledge of current Regulatory updates and Inspections
• Strong analytical and problem-solving skills
• Attention to detail and ability to work efficiently in a fast-paced environment
• Excellent communication and collaboration skills
• Ability to work independently and as part of a team
• Strong organizational skills and ability to manage multiple projects simultaneously