GM QAQC

As a Quality Assurance Manager, you will play a crucial role in ensuring the quality standards for all products and manufacturing activities. Your responsibilities will include: - Ensuring GMP compliance throughout the facility. - Organizing, educating, and executing activities in line with Quality Assurance objectives. - Handling customer audits effectively. - Releasing or rejecting APIs and Intermediates based on quality standards. - Keeping the workforce motivated and aligned with Company objectives. - Conducting OOS investigations as required. - Ensuring compliance with QMS, GMP, and GLP. - Managing Regulatory audits and compliance with agencies like USFDA, EU, TGA, WHO, Cofepress, and KFDA. - Handling Knowledge, Investigation, CAPA, Deviation, change control, Incident, lab error, Risk assessments, cleaning validation/ADE/PDE, and other quality-related aspects. - Qualification in electronic systems/software used in QC and instruments/equipment such as Lims, Chromeleon software, BPR, DMS, etc. - Managing Recall processes effectively. - Compiling compliance reports for various audits by external agencies and customers. - Conducting Vendor Audits and approvals. - Demonstrating good knowledge of Analytical Method Validation and Verification. - Reviewing APQR and Process verification reports. - Providing training to all employees as per CGMP standards. - Experience in the CDMO industry would be preferred. Your expertise in Quality Assurance will be instrumental in maintaining high-quality standards and ensuring compliance with regulatory requirements.,