GCP Lead

Job Description

Job Description Job Title: GCP Lead Employment Type: Full time Location: Bengaluru/India Experience: 5-8 Years About ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Canada, the United Kingdom, Italy, Poland, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities ¢ Performing QA functions pertaining to (but not limited to) Change management, CAPA, Deviation, Internal Audits, External Audits, Risk management, Innovation and Continual improvement.. Understanding GXP requirements such as (but not limited to) GCP, GVP, GMP, GDocP etc. and implementing/ monitoring them for QA function, as applicable. Facilitating the process of initiation of investigations and CAPAs, monitor progress and perform reviews/approvals. Ensuring that CAPA procedures and requirements are followed and met. Uphold standards for quality and compliance in pharmacovigilance. Escalating and involve stakeholders for resolution as needed, issues impacting the progress toward completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records. Reviewing evidence and approve closure of CAPA plans and effectiveness monitoring plans. Facilitating regular CAPA status and metric reports to ensure senior management awareness. Participating in governance/oversight activities including trend assessment or other quality review. Knowledge in the area of Clinical Operations is preferred. Required Skills and competencies: Quality Assurance Nonconformance management (CAPA, Deviations, Issues) GCP Stakeholder management Conflict Resolution Problem Solving