Job Title: Sr. QA Associate / QA Associate Clinical Trials Location: Mumbai Education: B.Pharm / M.Pharm / M.Sc. / B.Sc. / Life Sciences Job Description: We are looking for a proactive and detail-oriented Sr. QA Associate / QA Associate to join our Quality Assurance team for Clinical Trials. The ideal candidate will be responsible for ensuring GCP compliance across clinical trial activities, conducting internal and external audits, and supporting regulatory inspections in alignment with ICH-GCP, applicable regulatory requirements, and sponsor expectations. Key Responsibilities: Perform internal audits (e.g., system, process, and study-specific audits). Conduct vendor audits (e.g., clinical sites, laboratories, and service providers). Review and approve SOPs, protocols, CRFs, ICFs, and other essential trial documents. Ensure compliance with ICH-GCP, CDSCO, US FDA, EMA, and other applicable guidelines. Track and manage deviations, CAPAs, and non-conformance reports. Participate in inspection readiness activities and support sponsor/regulatory audits. Maintain QA metrics and dashboards for quality tracking and reporting. Provide GCP training to internal teams and vendor staff, as needed. Collaborate with cross-functional teams (Clinical, Regulatory, Data Management, etc.). Ensure timely escalation and resolution of quality issues. Desired Candidate Profile: 2 to 6 years of QA experience in Clinical Research, preferably in a CRO environment. In-depth knowledge of GCP, ICH guidelines, and applicable local/global regulations. Experience in conducting clinical trial audits (sites, systems, vendors). Strong verbal and written communication skills. Detail-oriented, analytical, and able to manage multiple projects simultaneously. Preferred Skills: Experience in handling sponsor or regulatory audits (e.g., USFDA, EMA). Familiarity with electronic QMS or eTMF systems. Certification in GCP or Quality Assurance will be an added advantage.