Position Quality Assurance QA Executive Experience 3-4 Years Department Quality Assurance Location Miyapur Hyderabad Industry Clinical Research Organization Key Responsibilities 1 Audit Compliance Conduct internal audits vendor audits investigator site audits and process audits as per the annual audit plan Ensure compliance with ICH-GCP USFDA EMA DCGI and other applicable regulatory standards Prepare detailed audit reports CAPA reviews and follow-ups 2 Quality Management System QMS Maintain and monitor QMS processes including SOP management deviations change controls CAPA and risk assessments Assist in drafting reviewing and implementing SOPs and ensuring periodic revisions 3 Document Training Management Oversee controlled documents ensure proper archival procedures and maintain document integrity Coordinate and monitor training programs for clinical and operational teams 4 Vendor Site Oversight Support qualification evaluation and periodic review of vendors e g laboratories clinical sites service providers Participate in vendor audits and maintain compliance documentation 5 Regulatory Support Support regulatory inspections and assist teams during FDA EMA DCGI or sponsor audits Ensure timely preparation of responses for audit findings and regulatory queries 6 Continuous Improvement Identify gaps in processes and suggest improvements Participate in root cause analysis and ensure effective implementation of CAPA Promote quality culture across the organization Key Skills Competencies Strong knowledge of ICH-GCP guidelines ethical principles and clinical trial processes Hands-on experience with QMS audits deviations CAPA and SOP management Excellent analytical documentation and communication skills Ability to work independently and collaborate with cross-functional teams Detail-oriented with strong organizational skills Educational Qualification Bachelor s or Master s degree in Life Sciences Pharmacy Biotechnology or related field Additional certifications in GCP Quality Management or Clinical Research are an added advantage Preferred Experience 3-4 years of experience in a CRO pharmaceutical or clinical research QA role Experience handling audits and interacting with regulatory authorities sponsors Exposure to eQMS systems is preferred Job Type Full-time Perks Provident Fund Work Location In person

📌 Quality Assurance Executive (Telangana)
🏢 Croissance Clinical Research
📍 Telangana