Pharmadesk Solutions Private Limited

Quality Oversight & ApprovalApprove analytical results, reports, protocols, methods, specifications, and other quality-related documents.Ensure the integrity, accuracy, and regulatory compliance of analytical and laboratory data.Provide final quality approval for services and deliverables provided to clients.2. Quality Management System (QMS)Establish, maintain, and continuously improve the Quality Management System (QMS) in compliance with GMP, GLP, and applicable regulatory guidelines.Ensure effective management of SOPs, deviations, CAPAs, change controls, OOS/OOT investigations, complaints, and risk management activities.Ensure data integrity compliance in line with ALCOA+ principles across all systems and documentation.3. Regulatory ComplianceEnsure compliance with applicable global regulations and guidelines, including FDA, EMA, ICH, WHO, and ISO standards.Lead, support, and manage regulatory inspections, client audits, and third-party audits.Act as the primary quality point of contact for regulatory authorities, auditors, and customers.4. Systems & ValidationReview and approve validation activities including analytical method validation, equipment qualification (IQ/OQ/PQ), computer system validation (CSV), and process validation.Ensure laboratory instruments, electronic systems, and software meet regulatory and data integrity requirements.5. Training & Quality CultureEnsure appropriate training of personnel on GMP, GLP, SOPs, and quality best practices.Promote and sustain a strong quality culture and compliance mindset across the organization.6. Risk Management & Continuous ImprovementIdentify potential quality and compliance risks and implement effective mitigation strategies.Drive continuous improvement initiatives to enhance regulatory compliance, operational efficiency, and service quality.