VIP Pharmaceuticals

1. Quality Management System (QMS) Establish, maintain, and continually improve the Quality Management System in compliance with WHO-GMP , EU-GMP , and Schedule M requirements. Review and approve SOPs , Change Controls , Deviations , CAPA , OOS/OOT , and Market Complaints . Conduct and oversee internal audits , vendor audits , and follow-up for compliance. Ensure effective implementation of data integrity principles in QA and QC operations. 2. Regulatory Compliance & Inspections Prepare and lead the site for WHO-GMP , EU-GMP , and national regulatory audits . Ensure timely submission and compliance of audit CAPAs. Stay updated on global regulatory changes and ensure readiness for audits by international agencies. 3. Documentation & Validation Review and approve Batch Manufacturing and Packaging Records (BMR/BPR) . Oversee equipment qualification , process validation , cleaning validation , and method validation activities. Maintain strict document control , record retention, and archival procedures in alignment with data integrity requirements. 4. Quality Control Oversight Supervise QC operations including Raw Material , In-Process , Finished Product , Stability , and Microbiology testing. Approve analytical methods, specifications, and ensure calibration and validation of laboratory instruments. Review and approve test reports, ensuring accuracy, traceability, and compliance. 5. Continuous Improvement & Risk Management Lead Quality Risk Assessments (QRA) and implement preventive and corrective actions. Drive continuous improvement initiatives to enhance quality, efficiency, and regulatory compliance. Analyze quality trends and implement measures for performance enhancement. 6. Training & Team Leadership Develop, train, and mentor QA and QC teams to ensure high competency and regulatory awareness. Conduct GMP, GDP, and Data Integrity training sessions across departments. Foster a culture of quality and accountability throughout the organization. Key Skills and Competencies: Comprehensive knowledge of WHO-GMP , EU-GMP , and ICH Q-series guidelines . Strong expertise in QMS, validation, audits, and documentation systems . Proven ability to handle regulatory inspections and customer audits . Leadership, analytical thinking, and decision-making capabilities. Excellent communication and cross-functional coordination skills.