Senior Executive - CQA

You will be responsible for preparing and adhering to the annual planner for Quality audits for Loan Licence Units (LLU), Third-Party Manufacturing Sites, public testing laboratories, and Shalina Operating Units (OUs) to ensure GMP and GLP compliance. This includes conducting periodic, due diligence, and for-cause quality audits to monitor overall performance. You will review audit compliance reports for any external, regulatory, or customer audits, ensuring the closure of individual observations by reviewing relevant supporting data. Additionally, you will conduct self-inspections of individual departments, compile reports, track and review compliance for timely closure, and maintain audit readiness of manufacturing sites. Coordinating the compilation and review of technical documents received from vendors for evaluation, arranging analysis of samples, conducting vendor qualifications, and implementing the onboarding processes in accordance with corporate quality standards will be part of your responsibilities. You will develop, implement, and conduct risk assessments and due diligence for new and existing vendors. Monitoring and evaluating vendor performance through KPIs, scorecards, and regular reviews, ensuring compliance with quality, regulatory, and contractual requirements will be crucial. Your role will involve planning, scheduling, and conducting internal and external quality audits, including vendor audits, and assessing vendor compliance with regulatory standards and internal SOPs. You will prepare audit plans, checklists, and reports with clear documentation of observations and non-conformities, follow up on audit findings, CAPA, and drive quality improvement initiatives across the vendor base. In addition, you will recommend process improvements based on audit trends, risk analysis, and vendor performance data. Providing training and guidance to internal teams and vendors on quality and compliance expectations, maintaining audit records, ensuring data integrity, traceability, and regulatory readiness will also be part of your responsibilities. Your skills should include a deep understanding of ISO standards, GxP, GMP, FDA regulations, ICH guidelines, and other applicable regulatory frameworks based on the industry. Proficiency in implementing, auditing, and maintaining QMS frameworks, ability to investigate non-conformities, strong writing skills for audit reports, SOPs, and compliance documentation, and interpreting audit trends and compliance metrics are essential. Having a strong problem-solving mindset, deep understanding of industry regulations, effective communication of audit findings, and compliance issues across all organizational levels will be critical for success in this role.,