GM/DGM QAQC

As a Quality Assurance Manager, your role will involve ensuring quality standards for all products and manufacturing activities. This includes maintaining GMP compliance throughout the facility and organizing activities in line with Quality Assurance objectives. Your responsibilities will also include handling customer audits, releasing or rejecting APIs and Intermediates, and ensuring the workforce is highly motivated and aligned with company objectives. You will be involved in OOS investigations, regulatory audits, and compliance with QMS/GMP/GLP standards. Key Responsibilities: - Ensure quality standards for all products and manufacturing activities - Maintain GMP compliance throughout the facility - Organize and execute activities according to Quality Assurance objectives - Handle customer audits - Release or reject APIs and Intermediates - Ensure workforce motivation and alignment with company objectives - Conduct OOS investigations - Ensure compliance with QMS/GMP/GLP - Handle Regulatory audit and compliance (USFDA/EU/TGA/WHO/Cofepress/KFDA) - Manage knowledge, investigations, CAPA, deviation handling, change control, incident management, and lab error handling - Conduct Risk assessments, cleaning validation/ADE/PDE, site master file preparation, Quality Manual development, VMP handling, and Data integrity management - Qualification in electronic systems/software used in QC and instrumentation/equipment, such as familiarity with Lims, chromeleon software, Electronic system for BPR, DMS - Handle recalls - Prepare compliance reports for various audits by outside agencies and customers - Conduct Vendor Audit and approval - Have good knowledge of Analytical Method Validation and Verification - Review APQR and Process verification reports - Provide training to all employees as per CGMP standards - Preference for candidates with experience in the CDMO industry Qualification Required: - Experience in handling electronic systems/software used in QC and instrumentation/equipment - Familiarity with Lims, chromeleon software, Electronic system for BPR, DMS - Good knowledge of Analytical Method Validation and Verification Note: The job description does not include any additional details about the company.,