QA - Clinical Trials & BA/BE Studies (5-8 Yrs)

Company Description

Novaspire Biosciences is a trusted partner in the pharmaceutical industry, providing comprehensive and high-quality clinical research services. With expertise across the drug and product development lifecycle, we specialize in clinical trials, pharmacovigilance, bioequivalence studies, medical writing, GxP consulting, and imaging studies. Backed by over 75 years of combined experience, our team supports pharmaceutical, biotechnology, medical device, and healthcare companies to ensure regulatory compliance, patient safety, and efficient market access. Novaspire is committed to delivering customized solutions and training aspiring clinical research professionals to excel in the industry.

Role Description

This is a full-time on-site role, based in Bengaluru, for a QA - Clinical Trials & BA/BE professional. The role involves ensuring compliance with quality systems, performing detailed quality control and assurance activities, managing Good Manufacturing Practices (GMP), and conducting quality audits. This individual will work closely with interdisciplinary teams to support clinical trials and bioavailability/bioequivalence studies by ensuring adherence to regulatory and quality standards.

Qualifications

• Proficiency in Quality Control and Quality Assurance activities
• Experience with Quality Management and Quality Auditing practices
• Understanding and application of Good Clinical Practice (GCP) standards
• Strong knowledge of regulatory requirements and compliance for clinical trials and BA/BE studies
• Excellent attention to detail and ability to ensure thorough documentation and reporting
• Experience in facing Sponsor Audits and Regulatory Inspections.
• Effective communication skills and capability to work in cross-functional teams
• Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Pharmacy, or a related field
• Experience in the pharmaceutical or clinical research industry (5-8 years preferred)